Devices and methods for tissue restoration

ABSTRACT

Devices and methods for tissue restoration. In at least one exemplary embodiment of an implantable restraining device of the present disclosure, the device comprises a first engaging component and a second engaging component at least substantially parallel to one another, a first swivel arm, comprising a first fixed arm, a first expandable arm, and a first hub, wherein the first fixed arm is pivotally connected to the first engaging component at or near a first fixed arm first end and is coupled to the first hub at or near a first fixed arm second end, and wherein the first expandable arm is pivotally connected to the second engaging component at or near a first expandable arm first end and is connected to the first hub at or near a first expandable arm second end by way of a first hub bracket, a second swivel arm, comprising a second fixed arm, a second expandable arm, and a second hub, wherein the second fixed arm is pivotally connected to the first engaging component at or near a second fixed arm first end and is coupled to the second hub at or near a second fixed arm second end, and wherein the second expandable arm is pivotally connected to the second engaging component at or near a second expandable arm first end and is connected to the second hub at or near a second expandable arm second end by way of a second hub bracket.

PRIORITY

The present U.S. continuation-in-part patent application is related to,and claims the priority benefit of, U.S. patent application Ser. No.12/861,251 filed Aug. 23, 2010, which is related to, claims the prioritybenefit of, and is a U.S. continuation-in-part application of, U.S.patent application Ser. No. 12/546,139, filed Aug. 24, 2009. Thecontents of each of these applications are hereby incorporated byreference in their entirety into this disclosure.

BACKGROUND

Organ and tissue surgical restoration are clinical techniques that maybe applied to numerous different body tissues, ranging from bloodvessels to whole organs. Conventionally, such surgical techniquesrequire the use of incisions, pins, staples and/or significant suturesin order to alter the tissue's anatomy. For example, surgical gastricrestoration often employed to treat obesity and typically involves thereorganization of the digestive tract. Conventional examples of suchprocedures involve attempts to either 1) restrict food intake into thebody via a restrictive bariatric procedure (a “Restrictive Procedure”),or 2) alter the anatomy of the small intestine or divert the peristalsisof a person's normal food intake past the small intestine to decreasecaloric absorption via a malabsorptive bariatric procedure, which iscommonly known as a gastric bypass (a “Malabsorptive Procedure”). It isalso known to combine the two procedures such that both of theaforementioned techniques are employed jointly.

Malabsorptive Procedures entail an intestinal bypass that results in theexclusion of almost all of the small intestine from the digestive tract.In most Malabsorbptive Procedures, a portion of the stomach or smallintestine is removed from the digestive tract through a surgicalprocedure that requires cutting the digestive tissue and thereafterclosing any holes or securing the newly formed anatomy with staplesand/or sutures. Conversely, Restrictive Procedures generally involve thecreation of a passageway extending from the upper portion of the stomachto the lower portion of the stomach in order to decrease the size of theorgan and thus prevent the stomach from storing large amounts of food.Conventional Restrictive Procedures rely on the banding, suturing and/orstapling of the stomach to create a small pouch on the superior portionof the stomach near the gastroesophageal junction.

Combined operations consisting of Malabsorptive and RestrictiveProcedures are the most common bariatric procedures performed today. Anexample of a combined procedure is the Extended (Distal) Roux-en-YGastric Bypass in which a stapling creates a small stomach pouch(approximately 15 to 20 cc) completely separated from the remainder ofthe stomach. In addition, the small intestine is divided just beyond theduodenum (the hollow tube connecting the stomach to the jejunum),re-arranged into a Y-configuration, and sutured to the small upperstomach pouch to enable the outflow of food therefrom through the newlyformed “Roux limb.”

Accordingly, most digestive tract restoration procedures require thatthe stomach and/or tissue of the intestine is cut and thereafter suturedor stapled back together. As the digestive tract contains numerousenzymes, strong acids and multiple species of bacteria that assist withdigestion, the perforation of an organ and/or tissue thereof isparticularly problematic due to the likelihood of leakage therefromand/or increased risk of serious infection. As such, conventionalgastric surgical restoration procedures have high rates ofpost-operative complications that may require prolonged hospitalizationand even additional operations, and are often irreversible and/orpermanently affect the restored tissue and/or organ. Accordingly, a needexists for safe and effective devices and methods for restoring organsand tissue that are reversible and do not require cutting or penetratingthe underlying tissue with significant sutures, staples and/or pins.

It will be appreciated that the foregoing examples are only provided asexamples and that there are numerous other indications whereintervention is necessary either to restore the underlying organ ortissue and/or to provide support thereto.

BRIEF SUMMARY

In at least one exemplary embodiment of an implantable restrainingdevice of the present disclosure, the device comprises a first engagingcomponent and a second engaging component at least substantiallyparallel to one another, a first swivel arm, comprising a first fixedarm, a first expandable arm, and a first hub, wherein the first fixedarm is pivotally connected to the first engaging component at or near afirst fixed arm first end and is coupled to the first hub at or near afirst fixed arm second end, and wherein the first expandable arm ispivotally connected to the second engaging component at or near a firstexpandable arm first end and is connected to the first hub at or near afirst expandable arm second end by way of a first hub bracket, a secondswivel arm, comprising a second fixed arm, a second expandable arm, anda second hub, wherein the second fixed arm is pivotally connected to thefirst engaging component at or near a second fixed arm first end and iscoupled to the second hub at or near a second fixed arm second end, andwherein the second expandable arm is pivotally connected to the secondengaging component at or near a second expandable arm first end and isconnected to the second hub at or near a second expandable arm secondend by way of a second hub bracket, and wherein the first expandable armand the second expandable are capable of movement relative to the firsthub and the second hub respectively so that a distance between the firstengaging component and the second engaging component may change relativeto movement of the first expandable arm and the second expandable arm.In another embodiment, the first swivel arm is capable of rotation in afirst direction, and wherein the second swivel arm is capable ofrotation in an opposing second direction. In yet another embodiment, thefirst swivel arm and the second swivel arm are capable of rotation sothat the first swivel arm, the second swivel arm, the first engagingcomponent, and the second engaging component share a common linear axis.In an additional embodiment, the first swivel arm and the second swivelarm are capable of rotation so that the first swivel arm and the secondswivel arm are substantially or fully perpendicular to the firstengaging component and the second engaging component. In yet anadditional embodiment, the first fixed arm is relatively shorter thanthe second fixed arm, and wherein the first expandable arm is relativelyshorter than the second expandable arm.

In at least one exemplary embodiment of an implantable restrainingdevice of the present disclosure, the device further comprises a firstarm flange at or near the first expandable arm second end, the first armflange configured to limit expansion of the first expandable armrelative to the first fixed arm, and a second arm flange at or near thesecond expandable arm second end, the second arm flange configured tolimit expansion of the second expandable arm relative to the secondfixed arm. In an additional embodiment, the device is sized and shapedto fit within a laparoscopic bodily port.

In at least one exemplary embodiment of an implantable restrainingdevice of the present disclosure, the device further comprises a firststrap positioned at a first end of the first engaging component and at afirst end of the second engaging component, the first strap configuredto limit movement of the first engaging component and the secondengaging component when the first strap is coupled to the first engagingcomponent and the second engaging component. In an additionalembodiment, the first strap is fixedly coupled to one of the first endof the first engaging component or the first end of the second engagingcomponent. In yet an additional embodiment, the first strap is coupledto one of the first end of the first engaging component or the first endof the second engaging component by way of at least one suture. Inanother embodiment, the first strap has at least one suture aperturedefined therethrough, and wherein at least one of the first engagingcomponent and the second engaging component has at least one plateaperture defined therethrough, the at least one suture aperture and theat least one plate aperture configured to permit a suture to be placedtherethrough to couple the first strap to either the first engagingcomponent or the second engaging component.

In at least one exemplary embodiment of an implantable restrainingdevice of the present disclosure, the device further comprises a firstpad coupled to one or both of the first fixed arm and the firstexpandable arm, and a second pad coupled to one or both of the secondfixed arm and the second expandable arm, wherein the first pad and thesecond pad are configured to engage at least a portion of a mammalianbodily organ positioned therebetween. In another embodiment, the firstengaging component and the second engaging component are configured toengage a targeted tissue therebetween when the first swivel arm and thesecond swivel arm are in a configuration relatively perpendicular to thefirst engaging component and the second engaging component. In yetanother embodiment, the first engaging component, the second engagingcomponent, the first swivel arm, and the second swivel arm each comprisea material suitable to resist corrosion selected from the groupconsisting of polyurethane, polyethylene, polytetrafluoroethylene,polyaryletherketone, carbothane, tecothane, nitinol, silastic, titanium,and stainless steel.

In at least one exemplary embodiment of an implantable restrainingdevice of the present disclosure, each of the first engaging componentand the second engaging component define one or more facets along atleast part of a length of said engaging components, said facetsproviding a generally arcuate profile of said engaging components. In anadditional embodiment, each of the first engaging component and thesecond engaging component comprise a configuration chosen from astraight bar configuration, a curved configuration, or a circularconfiguration. In yet an additional embodiment, the first engagingcomponent and the second engaging component are flexible orsemi-flexible.

In at least one exemplary embodiment of an implantable restrainingdevice of the present disclosure, the device comprises a first engagingcomponent and a second engaging component at least substantiallyparallel to one another, a first swivel arm, comprising a first fixedarm, a first expandable arm, and a first hub, wherein the first fixedarm is pivotally connected to the first engaging component at or near afirst fixed arm first end and is coupled to the first hub at or near afirst fixed arm second end, and wherein the first expandable arm ispivotally connected to the second engaging component at or near a firstexpandable arm first end and is connected to the first hub at or near afirst expandable arm second end by way of a first hub bracket, a secondswivel arm, comprising a second fixed arm, a second expandable arm, anda second hub, wherein the second fixed arm is pivotally connected to thefirst engaging component at or near a second fixed arm first end and iscoupled to the second hub at or near a second fixed arm second end, andwherein the second expandable arm is pivotally connected to the secondengaging component at or near a second expandable arm first end and isconnected to the second hub at or near a second expandable arm secondend by way of a second hub bracket, and a first strap positioned at oneor both of a first end of the first engaging component and at a firstend of the second engaging component, the first strap configured tolimit movement of the first engaging component and the second engagingcomponent when the first strap is coupled to the first engagingcomponent and the second engaging component. wherein the firstexpandable arm and the second expandable are capable of movementrelative to the first hub and the second hub respectively so that adistance between the first engaging component and the second engagingcomponent may change relative to movement of the first expandable armand the second expandable arm, and wherein the first swivel arm iscapable of rotation in a first direction so that the first swivel arm,the second swivel arm, the first engaging component, and the secondengaging component share a common linear axis, and wherein the secondswivel arm is capable of rotation in an opposing second direction sothat the first swivel arm and the second swivel arm are substantially orfully perpendicular to the first engaging component and the secondengaging component.

In at least one embodiment of a method for restoring a targeted tissueof the present disclosure, the method comprises the steps of insertingan implantable restraining device into a body cavity of a mammalianbody, the implantable restraining device comprising a first engagingcomponent and a second engaging component at least substantiallyparallel to one another, a first swivel arm, comprising a first fixedarm, a first expandable arm, and a first hub, wherein the first fixedarm is pivotally connected to the first engaging component at or near afirst fixed arm first end and is coupled to the first hub at or near afirst fixed arm second end, and wherein the first expandable arm ispivotally connected to the second engaging component at or near a firstexpandable arm first end and is connected to the first hub at or near afirst expandable arm second end by way of a first hub bracket, a secondswivel arm, comprising a second fixed arm, a second expandable arm, anda second hub, wherein the second fixed arm is pivotally connected to thefirst engaging component at or near a second fixed arm first end and iscoupled to the second hub at or near a second fixed arm second end, andwherein the second expandable arm is pivotally connected to the secondengaging component at or near a second expandable arm first end and isconnected to the second hub at or near a second expandable arm secondend by way of a second hub bracket, advancing the implantablerestraining device to a location within the mammalian body adjacent to atargeted tissue, swiveling the first swivel arm and the second swivelarm so that the first swivel arm and the second swivel arm aresubstantially perpendicular to the first engaging component and thesecond engaging component, and positioning the first engaging componentand the second engaging component over the targeted tissue such that atleast a portion of the targeted tissue is positioned therebetween,wherein when the targeted tissue expands in a direction between thefirst engaging component and the second engaging component, the targetedtissue exerts a force upon the first engaging component and the secondengaging component so that the first expandable arm moves relative tothe first hub and so that the second expandable arm moves relative tothe second hub. In another embodiment, the targeted tissue is a stomach,and wherein expansion of the stomach, with said device positionedthereon, functionally divides the stomach into a first stomach portionand a second stomach portion.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 and 2 show perspective views of at least one embodiment of arestraining device for restoring and/or supporting a tissue or organ ofthe present disclosure;

FIG. 3A shows a top view of at least one embodiment of a restrainingdevice for restoring and/or supporting a tissue or organ according tothe present disclosure;

FIGS. 3B through 3E show various embodiments of engaging componentsaccording to the present disclosure;

FIG. 4A shows a side view of the restraining device of FIGS. 1A and 1Bapplied in a longitudinal fashion to a stomach according to the presentdisclosure;

FIG. 4B shows a cross-sectional view of a restored stomach along lineA-A of FIG. 4;

FIGS. 5A through 5D show various embodiments of restraining devicespositioned about a stomach according to the present disclosure;

FIG. 6 shows a flow chart of a method for laparoscopically deliveringembodiments of the restraining device disclosed herein to a targetedtissue according to the present disclosure;

FIGS. 7A, 7B, and 8 show various embodiments of a restraining devicecomprising one or more struts according to the present disclosure;

FIG. 9 shows an exemplary embodiment of a restraining device comprisingtwo springs and a mesh curtain according to the present disclosure;

FIG. 10 shows an exemplary embodiment of a restraining device comprisinga pliable junction according to the present disclosure;

FIG. 11 shows a restraining device positioned within a laparoscopic portaccording to the present disclosure;

FIGS. 12A, 12B, 13A, and 13B show various embodiments of a restrainingdevice comprising a coupler according to the present disclosure;

FIGS. 14A and 14B show exemplary embodiments of a restraining devicecomprising a coupler and a coupler pivot according to the presentdisclosure;

FIGS. 15A and 15B show exemplary embodiments of an apparatus fordelivering a restraining device according to the present disclosure;

FIGS. 16A and 16B show exemplary embodiments of an apparatus fordelivering a restraining device comprising a coupler according to thepresent disclosure;

FIGS. 17A and 17B show additional exemplary embodiments of an apparatusfor delivering a restraining device according to the present disclosure;

FIG. 18 shows an exemplary embodiment of an apparatus perpendicularlyengaging a restraining device according to the present disclosure;

FIG. 19 shows a flow chart of a method for laparoscopically removingembodiments of the restraining device disclosed herein from a targetedtissue according to the present disclosure;

FIG. 20 shows a perspective view of at least another embodiment of arestraining device for restoring and/or supporting a tissue or organ ofthe present disclosure;

FIG. 21 shows an exemplary embodiment of a restraining device positionedabout a stomach according to the present disclosure;

FIG. 22 shows steps of an exemplary method of inserting, delivering, andplacing a restraining device about a targeted tissue according to thepresent disclosure;

FIG. 23 shows a perspective view of at least another embodiment of arestraining device for restoring and/or supporting a tissue or organ ofthe present disclosure;

FIG. 24 shows a side view of the embodiment of a restraining deviceshown in FIG. 23;

FIG. 25 shows a perspective view of an embodiment of an adjustment rodof the present disclosure;

FIG. 26 shows a side view of the embodiment of an adjustment rod shownin FIG. 25;

FIG. 27 shows a side view of an embodiment of an adjustment rod coupledto at least another component of an exemplary restraining device of thepresent disclosure;

FIG. 28 shows another perspective view of the embodiment of arestraining device shown in FIG. 23;

FIG. 29 shows steps of another exemplary method of inserting,delivering, and placing a restraining device about a targeted tissueaccording to the present disclosure;

FIG. 30 shows a perspective view of an exemplary embodiment of arestraining device of the present disclosure in a relatively openconfiguration;

FIG. 31 shows a perspective view of an exemplary embodiment of arestraining device of the present disclosure in a relatively openconfiguration;

FIGS. 32 and 33 show top views of an exemplary embodiment of arestraining device of the present disclosure;

FIG. 34 shows a side view of an exemplary embodiment of a restrainingdevice of the present disclosure in a relatively closed configuration;

FIG. 35 shows a perspective view of an exemplary embodiment of arestraining device of the present disclosure in a relatively closedconfiguration;

FIG. 36 shows a side view of an exemplary swivel arm of the presentdisclosure;

FIG. 37 shows a perspective view of an exemplary swivel arm of thepresent disclosure;

FIG. 38 shows a side view of another exemplary swivel arm of the presentdisclosure;

FIG. 39 shows a perspective view of another exemplary swivel arm of thepresent disclosure; and

FIGS. 40, 41, and 42 show exemplary embodiments of restraining devicesof the present disclosure positioned about a stomach.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the drawings, and specific language will be used todescribe the same. It will nevertheless be understood that no limitationof the scope of this disclosure is thereby intended.

FIGS. 1 and 2 show perspective views of at least one embodiment of arestraining device 10 for restoring a tissue or organ. In at least oneembodiment of the restraining device 10, the restraining device 10comprises an implantable device and does not require substantialsutures, staples or pins to be secured on the targeted tissue or organof interest. Further, the restraining device 10 described herein isconfigured to loosely, albeit securely, engage to the targeted tissuesuch that the underlying tissue is either uncompressed or only looselycompressed. The various embodiments of the restraining device 10described herein may be available for temporary or chronic placementwithin a patient's body, and the restoration procedures performedthrough the use of an exemplary device 10 are reversible throughminimally invasive procedures.

As shown in FIGS. 1 and 2, at least one embodiment of the restrainingdevice 10 comprises a first engaging component 12 and a second engagingcomponent 16. The first engaging component 12 may comprise a first shapeand the second engaging component 16 may comprise a second shape thatcorresponds to at least a portion of the first shape of the firstengaging component 12. For example, and without limitation, the firstand second engaging components 12, 16 may be configured in a barconfiguration as shown in FIGS. 1 and 2. Alternatively, the first andsecond engaging components 12, 16 may be configured in a contoured,circular or any other configuration suitable for use as referencedherein. Additionally, the first and second engaging components 12, 16may be configured such that the shape of each of the components 12, 16defines an interior area (not shown). It will be understood that thefirst and second engaging components 12, 16 of an exemplary restrainingdevice 10 may be configured in any shape and may also be flexible,semi-flexible, or articulated. Furthermore, it is contemplated that aclinician may select the desired configuration of the components 12, 16of the restraining device 10 based on the particular patient to betreated and/or pursuant to the specific application for which therestraining device 10 will be used to ensure that the restraining device10 appropriately conforms to the tissue or organ of interest. Forexample, an exemplary embodiment of a restraining device 10 of thepresent disclosure may comprise first and second engaging components 12,16 having a width of approximately 14 mm and a length of approximately120 mm. In at least one additional embodiment, the first and secondengaging components 12, 16 may have a width between 5 mm and 15 mm, andmay have a length between 30 mm and 200 mm, with any number of potentialwidths and lengths contemplated by the present disclosure suitable foruse with an exemplary restraining device 10 of the present disclosure.

In at least one embodiment of a restraining device 10 of the presentdisclosure, and as shown in FIG. 2, the first engaging component 12 ofthe restraining device 10 comprises a proximal end 13, a body having afirst side 12A and a second side 12B, and a distal end 14. The firstside 12A of the first engaging component 12 is configured to bepositioned adjacent to or in contact with a tissue or organ of interest.Likewise, the second engaging component 16 comprises a proximal end 17,a body having a first side 16A and a second side 16B, and a distal end18. The first side 16A of the second engaging component 16 is configuredto be positioned adjacent to or in contact with the tissue or organ ofinterest.

The first engaging component 12 and the second engaging component 16each comprise a material suitable to resist corrosion, such as andwithout limitation polyurethane, polyethylene, polytetrafluoroethylene(“PTFE”), nitinol, silastic, titanium, stainless steel or any othermaterial suitable for use in the medical arts that is corrosionresistant. Accordingly, the restraining device 10 can withstand chronicplacement within a body without the risk of deterioration. In at leastone embodiment, the first and second engaging components 12, 16 of therestraining device 10 are comprised of ultra high density polyethylene.

The first and second engaging components 12, 16 of the restrainingdevice 10 may be coupled to one or more springs 22, wherein the one ormore springs 22 engage the first and second engaging components 12, 16at their distal ends 14, 18 and proximal ends 13, 17. Springs 22, aswell as struts 700 (as shown in FIGS. 7A and 7B) and couplers 1200 (asshown in FIGS. 14A through 16B), as referenced herein, may be generallyreferred to as “connector(s)” as they connect, in various embodiments,first engaging components 12 and second engaging components 16 ofvarious restraining devices 10 of the present disclosure. The springs 22may comprise torsion springs or any other type of spring known ordeveloped that is capable of supporting the first and second engagingcomponents 12, 16 a prescribed distance apart from each other, which mayvary depending upon the orientation of the springs 22 about the firstand second engaging components 12, 16. As described in more detailherein, due to the configuration and resistance of the springs 22, thefirst and second engaging components 12, 16 of the restraining devicemay be held such that little or no space is defined between the firstsides 12A, 16A of the first and second engaging components 12, 16 basedupon a first orientation of springs 22, and the first and secondengaging components 12, 16 of the restraining device 10 may be held suchthat an interior space 70 is defined between the first sides 12A, 16A ofthe first and second engaging components 12, 16 based upon a secondorientation of springs 22.

Further, each of the one or more springs 22 may have any number of coilsconfigured in any fashion, provided the spring configuration andstiffness are suitable for the desired application of the restrainingdevice 10. For example, and without limitation, in at least oneembodiment each of the one or more springs 22 comprises a torsion,resistance spring having three (3) closely-coiled coils. It will beappreciated that, in practice, a clinician may alter the number of coilsand/or configuration of each spring 22 to achieve to a desiredflexibility or rigidity of the springs 22 and, in this manner, therestraining device 10 may be customized for a particular patient and/orapplication for which the restraining device 10 is to be applied.

Each of the springs 22 of the restraining device 10 may comprise atleast one rod 24 extending from each of the ends of its coils. Thelength of each rod 24 may be selected depending on the particularapplication for which the restraining device 10 is to be applied. Asshown in the exemplary embodiments of a restraining device 10 in FIGS. 1and 2, each rod 24 is coupled with either the first or second engagingcomponent 12, 16. For example, as shown in FIG. 2, the first rod 24 ofone of the springs 22 may be coupled with the second side 12B of thefirst engaging component 12 at or near a location on the distal end 14of the first engaging component 12, and the second rod 24 of the samespring 22 may be coupled with the second side 16B of the second engagingcomponent 16 at or near a location on the distal end 18 of the secondengaging component 16. Furthermore, the rods 24 facilitate the formationof the interior space 70 (as shown in FIG. 2) between the first andsecond engaging components 12, 16 by holding the first and secondengaging components 12, 16 in accordance with the tension of the springs22.

The springs 22 of the restraining device 10 may comprise any dimensionsso long as the restraining device 10 is of a sufficient size to movethrough a laparoscopic port and the springs 22 are capable of holdingthe first side 12A of the first engaging component 12 and the secondside 16A of the second engaging component 16 a distance apart when therestraining device 10 has a configuration whereby the springs 22 arepositioned about the first and second engaging components 12, 16. Forexample, springs 22 may have a “first” configuration as shown in FIG. 1,whereby springs 22 and the first and second engaging components 12, 16are oriented in the same or substantially the same direction/plane sothat the restraining device 10 may pass through a laparoscopic port. Insuch a first configuration, springs 22 engage the first and secondengaging components 12, 16 so that the first and second engagingcomponents 12, 16 either engage one another or have a relatively smallspace between them. Springs 22 may have a “second” configuration, forexample and as shown in FIG. 2, when springs 22 are rotated about firstand second engaging components 12, 16 and are not in the samedirection/plane as the configuration of restraining device shown inFIG. 1. In such a second configuration, the first and second engagingcomponents 12, 16 may define an interior space 70 when the restrainingdevice 10 is “at rest,” with the interior space 70 increasing uponpositioning the restraining device 10 around a stomach 100 (as shown inFIGS. 4A through 5A) for example, and potentially increasing onlyslightly further upon introduction of food, for example, into thestomach 100.

Accordingly, the dimensions of the springs 22 may dictate the nativevalue of the interior space 70 between the first and second engagingcomponents 12, 16. In at least one embodiment, the springs 22 maycomprise a maximum outside diameter that is less than about 14millimeters to allow a “collapsed” or “compressed” restraining device 10to pass within a 15 mm diameter abdominal port. Furthermore, each of thesprings 22 may comprise any material having a strength that is consonantwith the application for which the restraining device 10 will beemployed. In at least one embodiment, the springs 22 are comprised of arigid or semi-rigid material that is suitable to resist corrosion, suchas and without limitation, polyurethane, PTFE, nitinol, silastic,titanium, stainless steel or any other material suitable for use in themedical arts that is corrosion resistant.

Referring back to FIG. 2, and as previously described, the springs 22 ofthe restraining device 10 are biased to maintain the first and secondengaging components 12, 16 at a prescribed distance apart under anative, and as described above, “second” configuration. In this manner,when no pressure is applied to an exemplary restraining device 10—orwhen the restraining device 10 is “at rest”—the interior space 70 havinga prescribed value is formed between the first and second engagingcomponents 12, 16. The value of the interior space 70 may, in at leastone embodiment, correlate with the outside diameter of the springs 22,minus the thickness of the first and second engaging components 12, 16.It will be understood that the value of the interior space 70 can bemanipulated by a clinician depending on the thickness of tissue and/ororgan to be treated or other factors. For example, to achieve aninterior space 70 having a larger prescribed value, the outer diameterof the spring 22 may be increased and/or the thickness of the firstand/or second engaging components 12, 16 may be adjusted. Accordingly, aclinician can easily modify the restraining device 10 such that it maybe optimally configured for a particular application on a particulartissue.

Due to the nature of the springs 22 (depending on the material andrigidity selected), the first and second engaging components 12, 16 mayexhibit some degree of “give” such that the first and second engagingcomponents 12, 16 are capable of moving relative to each other whenpressure is applied. While the first and second engaging components 12,16 are biased to return to their resting position such that the interiorspace 70 is substantially equivalent to its prescribed/native value whenno pressure is applied to the springs 22, the springs 22 of therestraining device 10 are also capable of allowing the first and secondengaging components 12, 16 to move in response to force applied thereto.For example, and without limitation, if a force is applied against thefirst sides 12A, 16A of the first and second engaging components 12, 16,this force is translated to the springs 22 which enables the components12, 16 of the restraining device 10 to move apart such that the interiorspace 70 is increased. Furthermore, if a force is applied directly tothe springs 22 such that the coils are twisted about their axis in adirection counter to the coil configuration, similar to the above-listedexample, the resultant effect on the restraining device 10 is that thefirst and second engaging components 12, 16 are moved apart and theinterior space 70 is increased. However, due to the inherent biasprovided by the springs 22 of the restraining device 10, after thepressure affecting the springs 22 is released, the springs 22—and thusthe components 12, 16—return to their resting positions such that theinterior space 70 reverts to its original prescribed value. It will beappreciated that the specific configuration and/or materials comprisingeach of the springs 22 may be selected to achieve the desired degree ofelasticity depending on the application for which the restraining device10 is to be applied.

As shown in FIG. 2, each rod 24 of spring 22 is rotatably coupled withthe relevant component 12, 16 of the restraining device 10 such thateach of the rods 24 is capable of pivotal movement with respect to therelevant component 12, 16 of the restraining device 10. The rotationalcoupling of the rods 24 with the first and second engaging components12, 16 may be achieved through any means known in the art. For exampleand without limitation, the end of each rod 24 may comprise a pin thatis capable of insertion into and rotation within a hole formed withinthe respective second side 12B, 16B of the applicable component 12, 16.

As each of the rods 24 is coupled with a spring 22, when the rods 24rotate with respect to the components 12, 16, this effectively enablesthe respective spring 22 to move in an orbital manner with respect tothe proximal or distal end of the restraining device 10. Accordingly,the springs 22 are capable of rotating between a position that issubstantially parallel with the first and second engaging components 12,16 (as shown in FIG. 1, referred to as a “first” configuration herein)and a position that is substantially perpendicular to the first andsecond engaging components 12, 16 (as shown in FIG. 2, referred to as a“second” configuration).

The position of the springs 22 relative to the first and second engagingcomponents 12, 16 has the potential to significantly affect the overallwidth of the restraining device 10. For example and without limitation,when the springs 22 are positioned in the substantially perpendicularposition (i.e., a “second” configuration), the restraining device 10 mayhave a width that is more than twice the width of the same restrainingdevice 10 when its springs 22 are positioned in the substantiallyparallel position. Accordingly, the rotational coupling of the rods 24with the first and second engaging components 12, 16 provides aclinician with the ability to manipulate the overall width of therestraining device 10 during laparoscopic delivery and/or implantationand further enables the restraining device 10 to be applied to tissuesand/or organs having a length that is longer than the length of therestraining device 10 (as the proximal ends 13, 17 and the distal ends14,18 of the first and second engaging components 12, 16 of therestraining device 10 are not obstructed by the springs 22). In at leastone embodiment, the widest part of the restraining device 10 is lessthan about 15 millimeters when the springs 22 are in the substantiallyparallel position such that the restraining device 10 can be easilyinserted into a body cavity through a 15 millimeter trocar or port.

Now referring to FIG. 3A, a top view of at least one embodiment of arestraining device 10 of the present disclosure is shown. Here, thefirst and/or second engaging components 12, 16 of the restraining device10 further comprise one or more pads 30 extending therefrom. As shown inFIG. 3A, the one or more pads 30 may extend in a perpendicular fashionfrom the second side(s) 12B, 16B of the components 12, 16 and/or in alateral fashion from the components 12, 16. Each of the pads 30 arecomprised of a flexible material and configured to provide an anchorthrough which sutures or any other type of anchoring device may beinserted. For example, and in at least one embodiment, one or more pads30 may be comprised of polyurethane or any other material that iscapable of securely holding sutures or another type of anchoring devicetherein. One or more sutures may be placed within suture apertures 32 asshown in FIG. 3A, whereby said suture apertures 32 may be positionedalong pads 30 and/or one or both of components 12, 16 as shown in FIG.3A. Accordingly, after the first and second engaging components 12, 16are properly positioned about a targeted tissue or organ, sutures may beinserted through suture apertures 32 and secured to a superficial layerof the underlying targeted tissue or organ to assist in anchoring therestraining device 10 in the proper location thereon.

FIGS. 3B-3E show various embodiments of first engaging component 12and/or second engaging component 16 with various features to facilitatesuturing and/or connection of first engaging component 12 to secondengaging component 16. FIG. 3B shows an exemplary embodiment if a firstand/or second engaging component 12, 16 comprising suture apertures 32positioned therethrough. Suture apertures 32 are not limited topositioning near one or more of the ends of said first and/or secondengaging component 12, 16, as such suture apertures 32 may be positionedalong first and/or second engaging component 12, 16 as desired.

FIG. 3C shows an exemplary embodiment of a first and/or second engagingcomponent 12, 16 comprising one or more strings 34 affixed thereto. Inthe exemplary embodiment shown in FIG. 3C, two strings 34 are shown ator near the ends of first and/or second engaging component 12, 16,noting, however, that one, two, or more strings 34 may be affixedthereto and positioned as desired. In an exemplary embodiment of arestraining device 10, and as shown in FIG. 4B, the first engagingcomponent 12 and the second engaging component 16 may each comprise atleast one string 34, whereby said strings 34 may be connected to oneanother to facilitate a desired placement of restraining device 10 abouta stomach 100.

Additional embodiments of exemplary first and/or second engagingcomponents 12, 16 are shown in FIGS. 3D and 3E. As shown in FIG. 3D,first and/or second engaging component 12, 16 comprises one or moresuture members 36 affixed thereto, with said suture members defining anaperture to which a suture (not shown) or other restraining componentmay be affixed thereto. FIG. 3E shows an exemplary first and/or secondengaging component 12, 16 of the present disclosure comprising pads 30positioned at or near each end of the first and/or second engagingcomponent 12, 16 with each pad 30 defining a suture aperture 32therethrough. Additional embodiments of first and/or second engagingcomponent 12, 16 comprising features to allow for a suture or otherrestraining component to be positioned therethrough are alsocontemplated by the present disclosure. For purposes of the presentdisclosure, the term “suturing elements” shall mean any number ofelements for introducing a suture into the first and/or second engagingcomponent 12, 16 and/or one or more pads 30 affixed thereto, including,but not limited to, one or more apertures 32, strings, 34, and/or suturemembers 36. In addition, any number of the features of the variousexemplary first and/or second engaging components 12, 16 shown in FIGS.3A-3E may appear in any number of embodiments of restraining devices 10of the present disclosure.

In operation, the restraining device 10 may be applied to an organ ortissue of interest in order to restore the underlying tissue or organinto a desired configuration and/or provide support to the same. Asdiscussed in further detail below, the restraining device 10 may be usedfor temporary or chronic implantation within a body without the risk ofthe first and second engaging components 12, 16 migrating through ordamaging the underlying tissue. Furthermore, because the restrainingdevice 10 does not require that the underlying tissue be punctured inany significant manner to achieve restoration and/or provide supportthereto, implantation of the restraining device 10 is entirelyreversible and, if desired, the restraining device 10 may be easilyremoved from the organ or tissue of interest through a laparoscopicprocedure.

As previously described, the specifications of the restraining device 10may be modified to achieve a desired result. For example, and withoutlimitation, the dimensions of the components 12, 16 and/or the springs22 may be chosen for a particular application and/or based on thepatient. Accordingly, while certain embodiments of the restrainingdevice 10 may be described in connection with particular tissues ororgans, it will be appreciated that any of the embodiments of therestraining device 10 described herein may also be applied to any tissueor organ of interest in a similar manner and use of the particularembodiments of the restraining device 10 in lieu of others may bedetermined based on the patient's specifications, the specificapplication, and/or the tissue or organ in question.

In practice, an exemplary restraining device 10 is capable of restoringand/or supporting an underlying tissue while avoiding constriction andthe excessive compression thereof. For example, the restraining device10 may be applied to a stomach 100 as shown in FIGS. 4A and 4B. In atleast one embodiment, and as shown in FIG. 4A, the springs 22 of therestraining device 10 are rotated to the substantially perpendicularposition such that the interior space 70 is increased between the firstand second engaging components 12, 16. Thereafter, the restrainingdevice 10 may be advanced over the stomach 100 such that, for example,the first side 12A of the first engaging component 12 is positionedadjacent to the anterior wall of the stomach 100 and the first side 16Aof the second bar 16 is positioned adjacent to the posterior wall of thestomach 100. While the restraining device 10 is shown in FIG. 4A in alongitudinal placement with respect to the stomach 100, it will beunderstood that the restraining device 10 may alternatively bepositioned in a horizontal configuration or an angular configurationwith respect to the stomach 100.

After the first and second engaging components 12, 16 are positioned inthe desired location with respect to the stomach 100, the overallinterior space 70 may either comprise its original native interior space70 or a relatively larger interior space 70 due to the positioning ofthe restraining device 10 about the stomach 100. Therefore, variousembodiments of restraining device 10 do not operate to “clamp” thestomach 100 or any other tissue or organ, as restraining device 10merely operates, when positioned around a stomach 100, to provide alimited pressure, if any, to maintain a native size/shape of at least aportion of the stomach 100. For example, and depending upon theprescribed value of the interior space 70 as desired by a clinician, theconfiguration of the springs 22 can be modified to achieve a restrainingdevice 10 that either does not compress, or only loosely compresses, thesandwiched tissue between the first and second engaging components 12,16. In a preferred embodiment, restraining device 10, when positionedabout a stomach 100, does not provide any meaningful compressivepressure upon the stomach 100, and may be held in place, for example,using one or more sutures as referenced herein. In this manner, therestraining device 10 can be employed to reversibly restore an organ ortissue without forming adhesions thereon and/or permanently restoringthe same.

In at least one embodiment, and depending on the configuration of thesprings 22, the springs 22 may exhibit enough elasticity to enable thefirst and second engaging components 12, 16 to move to some degree inconjunction with any movement of a tissue or organ positioned betweenthe first and second engaging components 12, 16 of the restrainingdevice 10. In this manner, the springs 22 can allow, for example, therestraining device 10 to accommodate any inherent movement in thestomach 100 such that application of the restraining device 10 does notcompletely inhibit the normal digestive function of the same. Forexample, the introduction of food into the stomach 100 may cause theouter dimensions of the stomach 100 to expand, whereby stomach 100exerts a pressure upon restraining device 100. Furthermore, therestraining device's 10 ability to accommodate any inherent movement inthe underlying organ and/or tissue increases the likelihood that therestraining device 10 will remain in its desired location on the tissueand/or organ without sheering off or sliding therefrom.

In the event it is desired that the restraining device 10 is furthersecured to the underlying tissue, and as previously referenced herein, aclinician can employ sutures to assist with the secure implantation ofthe restraining device 10 in the desired location. In the at least oneembodiment of the restraining device 10 comprising the one or more pads30, a clinician can secure the one or more pads 30 of the first andsecond engaging components 12, 16 to the underlying tissue through theuse of superficial sutures. In this manner, the superficial sutures canbe affixed through the one or more pads 30 and the surface of theunderlying tissue such that the one or more pads 30 assist withanchoring the restraining device 10 in position on the tissue ofinterest. Conversely, and in at least one embodiment, sutures may beintroduced directly to the first and/or second engaging components 12,16 to secure a restraining device to a tissue or organ of interest asshown in FIGS. 3A-3E.

FIG. 4B shows a cross-sectional view of the stomach 100 of FIG. 4A takenalong A-A. As shown in FIG. 4B, when the first and second engagingcomponents 12, 16 of the restraining device 10 are longitudinallypositioned on the stomach 100, the stomach 100 is “divided” into twoportions—a first stomach portion 110 and a second stomach portion 112 asshown in FIGS. 4A and 4B. In the embodiment shown in FIGS. 4A and 4B,the first stomach portion 110 is relatively smaller than the secondstomach portion 112. However, and as shown in FIG. 5A, the first stomachportion 110 and the second stomach portion 112 may be approximately thesame size.

As the first stomach portion 110 receives ingested matter directly fromthe gastroesophageal junction 99 as shown in FIG. 4A, the placement ofthe restraining device 10 as shown in FIG. 4B thus inhibits the majorityof ingested matter from moving into the second stomach portion 112.Instead, and in at least one embodiment, such ingested matter isdirected through the smaller, first stomach portion 110 and into thepyloric canal 101 (as shown in FIG. 4A) where a significant portion ofthe ingested matter is evacuated from the stomach 100. Due to the sizeof the first stomach portion 110, the amount of food that the patientcan consume at one time is significantly reduced and satiety is morequickly achieved.

While the delineation formed by the restraining device 10 between thefirst stomach portion 110 and the second stomach portion 112 is notleak-proof, the interior space 70 created between the first and secondengaging components 12, 16 comprises an area that is less than thediameter of a fully extended stomach 100 (as shown in FIG. 4B).Accordingly, when the restraining device 10 is applied in a longitudinalfashion to a stomach 100, restraining device 10 provides support to theanterior and posterior walls of the stomach 100, with the expansion ofstomach 100 exerting a force onto the first and second engagingcomponents 12, 16 of restraining device 10, this preventing stomach 100distension in that area. In this manner, most of the food matterreceived into the first stomach portion 110 through the gastroesophagealjunction 99 is maintained therein and the patient exhibits the sensationof satiety earlier.

Referring back to FIG. 4A, and in at least one exemplary embodiment,because the restraining device 10 does not extend along the entirelength of the stomach 100, an outflow tract 114 is formed caudally ofthe restraining device 10. This outflow tract 114 allows the portion ofingested matter that flows from the gastroesophageal junction 99 intothe second stomach portion 112 to be evacuated from the stomach 100 in acontrolled manner and to proceed through normal digestion. In addition,the outflow tract 114 allows any food matter or enzymes residing withinthe second stomach portion 112 to evacuate the stomach 100.

Additional embodiments of restraining devices 10 of the disclosure ofthe present application positioned about a stomach 100 are shown inFIGS. 5B and 5C. In the exemplary embodiment shown in FIG. 5B,restraining device 10 comprises first and second engaging components 12,16 which are “longer” than those shown in FIG. 5A, whereby distal end 14of first engaging component 12 and distal end 18 of second engagingcomponent 16 extend past stomach 100. In this exemplary embodiment,strings 34 affixed to first and second engaging components 12, 16 may beconnected/tied to each other after restraining device 10 has beenpositioned about a stomach, maintaining restraining device 10 in place.

FIG. 5C shows restraining device 10 positioned about stomach 100 viewedin the direction of the arrow shown in FIG. 5B. As shown in FIG. 5B, thetying/coupling together of strings 34 at the distal ends 14, 18 of firstand second engaging components 12, 16 may cause portions of the firstand second engaging components 12, 16 to angle towards one another asshown in FIG. 5C. In this particular embodiment, first and secondengaging components 12, 16 are flexible or semi-flexible, and thepositioning of restraining device 10 about stomach 100 serves to isolatethe first stomach portion 110 from fundus 90 and greater curvature 92.This “funnel” effect, in addition to the embodiment of a restrainingdevice 10 shown in FIG. 5D below, may also be accomplished by havingsprings 22 with relatively shorter rods 24 (or relatively smaller struts700 as referenced in various embodiments herein) at one end ofrestraining device 10, and by having springs 22 with relatively longerrods 24 (or relatively larger struts 700 as referenced in variousembodiments herein) at the other end of restraining device 10. Inaddition as to being substantially rigid as shown in FIGS. 1 and 2, andas shown in FIG. 5C, first and second engaging components 12, 16 mayhave substantially rigid center portions and one or more flexible orsemi-flexible ends, or first and second engaging components 12, 16 maybe flexible or semi-flexible along the entirety of said components 12,16.

An additional embodiment of a restraining device 10 of the presentdisclosure positioned about stomach 100 is shown in FIG. 5D. As shown inFIG. 5D, and as also discussed herein regarding FIG. 10, restrainingdevice 10 further comprises a pliable junction 1000 positioned withinthe first engaging component 12 and second engaging component 16,effectively “splitting” each component, whereby each “split” componentis connected to one another by way of a flexible structure 1002. Asshown in FIG. 5D, flexible structure 1002 may comprise a PTFE band or aPTFE mesh, for example, whereby any potential embodiment of flexiblestructure 1002, using one or more pliable materials disclosed herein orotherwise known in the art, allows the relatively or fully rigid firstengaging component 12 and second engaging component 16 to better fit thestomach, allowing the patient, for example, to bend the stomach whenrestraining device 10 is positioned thereon.

Approximating first and second engaging components 12, 16, as shown inFIGS. 5B, 5C, and 5D, and as identified during internal testing ofexemplary restraining devices 10 of the present disclosure, leads toreduced food intake (65-70% of normal food intake) as compared topositioning restraining device 10 about stomach 100 withoutapproximating first and second engaging components 12, 16 toward oneanother as shown in FIG. 4A (80-85% of normal food intake). Thisapproximation also assists with the prevention of a fistula so that thefood may move down the pouch (first stomach portion 110) along antrum 94as opposed to shunted to the fundus 90 of stomach 100.

As described herein, application of the restraining device 10 allows aclinician to restore a targeted tissue, such as a stomach 100, whileavoiding constriction and excessive compression of the same. Further,the various embodiments described herein allow a clinician to tailor therestraining device 10 to multiple restoration applications and variousdifferent types of tissues. Permanent restoration of the tissue isavoided, which prevents adhesions from developing in the underlyingtargeted tissue and allow for the complete reversal of the restorationprocedure. Additionally, the restraining device 10 is simple to deliverand, as such, the device 10 may be used in conjunction with othertechniques or surgical procedures.

Regarding the application of the restraining device 10 to the stomach100, use of the restraining device 10 in the treatment of obesity avoidsthe nutritional and metabolic deficiencies observed after MalabsorptiveProcedures because the digestive process may continue within the stomachas with a native stomach 100. In addition, the restraining device 10does not require more than superficial punctures to the underlyingtissue, nor does it employ pins, staples or significant sutures whichmay lead to dehiscence or fistula formation, or produce the degree ofregurgitation and vomiting observed in connection with conventionalmethods used to treat obesity. Moreover, each of the embodimentsdescribed herein may be inserted into the body cavity laparoscopically,thereby decreasing the patient's stress associated with the procedureand the patient's recovery time. It will be recognized that any of thedevices described herein may be employed in combination with otherconventional bariatric procedures.

Now referring to FIG. 6, a flow chart of a method 300 forlaparoscopically delivering the restraining device 10 is shown. For easeof understanding, the steps of the related methods described herein willbe discussed relative to the components of an exemplary restrainingdevice 10. Furthermore, while the methods described herein are describedin connection with embodiments of the restraining device 10 and anexemplary delivery device, it will be appreciated that variousadditional devices may be used to facilitate the laparoscopic deliveryof the restraining device 10 such as a camera, light and/or a device fordelivering a gas to a targeted area.

At step 302, the first and second engaging components 12, 16 ofrestraining device 10 are advanced laparoscopically into the patient'sbody. In at least one embodiment, the restraining device 10 may beinserted through a 15 millimeter cannula under insufflation into theappropriate cavity of the patient's body. This may be achieved throughuse of an exemplary delivery device known in the art. At this step 302,the springs 22 of the restraining device 10 are positioned in thesubstantially parallel position such that the overall diameter of therestraining device 10 is sufficiently narrow for insertion into thebody.

At step 304 the restraining device 10 is advanced to a location adjacentto a targeted tissue. In the at least one embodiment of the method 300where an exemplary delivery device is employed to facilitate delivery ofthe restraining device 10 to the targeted tissue, at step 304 therestraining device 10 is advanced out of the delivery device and intothe body cavity. After the restraining device 10 is no longer positionedwithin an exemplary delivery device, the delivery device may bewithdrawn from the body cavity at this step 304 or as desired by theclinician.

At step 306, the springs 22 of the restraining device 10 are rotatedfrom the substantially parallel position to the substantiallyperpendicular position, separating the first and second engagingcomponents 12, 16 from one another to a native interior space 70. Step306 may be performed using any number of standard laparoscopic toolsknown in the art useful to pull and grasp portions of a tissue or adevice. In this manner, neither the proximal ends 13, 17 nor distal ends14, 18 of the first and second engaging components 12, 16 of therestraining device 10 are blocked by the springs 22 and/or rods 24, andthe first and second engaging components 12, 16 may be advanced over atargeted tissue having a length that is greater than the overall lengthof the first and second engaging components 12, 16.

At step 308, under fluoroscopic, direct camera control or otherwise, therestraining device 10 is advanced over the targeted tissue. In at leastone embodiment, and at step 308, the first side 12A of the firstengaging component 12 is positioned adjacent to the desired surface ofthe targeted tissue and the first side 16A of the second engagingcomponent 16 is positioned adjacent to an opposite side of the targetedtissue. As the first and second engaging components 12, 16 of therestraining device 10 are positioned adjacent to opposite sides of thetargeted tissue, at this step 308 the targeted tissue is positionedwithin the interior space 70 formed between the first and secondengaging components 12, 16. Accordingly, while the targeted tissue mayexperience some compressional force exerted by the first and secondengaging components 12, 16 of the restraining device 10, the majority ofthe pressure upon the first and second engaging components 12, 16 isprovided by distension/expansion of the targeted tissue (for example,expansion of a stomach 100 when food is introduced therein). Further,due to the configuration and composition of the restraining device 10,the restraining device 10 can remain within the patient's body for aslong as the restoration or support treatment delivered thereby isdesired.

If preferred, in at least one embodiment of the restraining device 10that further comprises one or more pads 30 coupled with the first and/orsecond engaging components 12, 16, the method 300 may advance from step308 to step 310. At step 310, a clinician can employ sutures to furtheranchor and secure the restraining device 10 in the desired position onthe targeted tissue. These sutures need only superficially puncture theunderlying tissue and therefore are not associated with the negativeeffects associated with suturing, stapling and/or the insertion of pinsused in conventional methods.

Additional embodiments of restraining devices 10 of the disclosure ofthe present application is shown in FIGS. 7A and 7B. As shown in FIGS.7A and 7B, restraining device 10 comprises a first engaging component 12and a second engaging component 16, whereby the first engaging component12 and second engaging component 16 are coupled to one another by way ofone or more struts 700. In the exemplary embodiment shown in FIGS. 7Aand 7B, four struts 700 and five struts 700 are used, respectively, butany number of struts 700 may be used as desired for a particularapplication. Struts 700 may comprise any number of suitable materials asotherwise described herein, including, but not limited to, nitinol andstainless steel. Struts 700, in an exemplary application, would have apre-established “open” size and a pre-established “strength”, so thatrestraining device, in a native “rest” configuration, would be “open”(by way of, for example, the “memory” of struts 700) and would requiresome sort of pressure/force to open even further. The “open”configuration would keep first engaging component 12 and second engagingcomponent 16 a fixed distance apart to avoid gastric tissue compressionwhen positioned about a stomach.

An exemplary restraining device 10 may further comprise a mesh curtain702 coupled to struts 700 as shown in FIGS. 7A and 7B. Mesh curtain 702may prevent or limit potential organ distension or remodeling whenrestraining device 10 is positioned about an organ of interest. A demishaft 704, as shown in FIGS. 7A and 7B, may be positioned around atleast part of struts 700 and/or mesh curtain 702 to facilitate insertionof restraining device 10 within a body. For example, and as shown inFIG. 7A, restraining device 10 may be seen as inserted within a body,noting that restraining device is somewhat compressed by demi shaft 704,to facilitate insertion through, for example, a laparoscopic port. Afterinsertion, and as shown in FIG. 7B, demi shaft 704 may be withdrawn inthe direction of the arrow (shown as partially withdrawn in the figure)to allow restraining device 10 to obtain its original, uncompressedconfiguration, and ultimately removed from the body. Struts 702 may havea first configuration when positioned within demi shaft 704, as shown inFIG. 7A, and may have a second configuration when demi shaft 704 isremoved, as shown on the left side of FIG. 7B.

When restraining device 10 is in its native configuration, it may thenbe positioned about a stomach, for example, and the user positioningrestraining device 10 may grasp stomach tissue using any number oflaparoscopic tools through mesh aperture 706 as shown in FIGS. 7B and 8.As shown in FIG. 8, an exemplary restraining device 10 may also compriseone or more suture members 36 to allow one or more sutures (not shown)to be used to secure restraining device 10 to, for example, an anteriorgastric wall.

An additional embodiment of a restraining device 10 of the disclosure ofthe present application is shown in FIG. 9. As shown in FIG. 9,restraining device 10 comprises a first engaging component 12 and asecond engaging component 16, whereby first engaging component 12 andsecond engaging component 16 are coupled to one another by way of one ormore springs 22. In this exemplary embodiment, restraining device 10further comprises a mesh curtain 702 coupled to first engaging component12 and second engaging component 16, whereby mesh curtain 702 mayprevent or reduce organ distension or remodeling when restraining device10 is positioned about an organ. The flexibility/pliability of meshcurtain 702 would allow mesh curtain 702 to be closely positioned firstengaging component 12 and second engaging component 16 upon insertion ofrestraining device 10 within a body, and may further allow mesh curtain702 to expand in a direction of springs 22 as shown in FIG. 9, forexample, to prevent organ distention.

FIG. 10 shows yet another embodiment of a restraining device 10 of thepresent application. As shown in FIG. 10, restraining device comprises afirst engaging component 12 and a second engaging component 16, wherebyfirst engaging component 12 and second engaging component 16 are coupledto one another by way of one or more springs 22. However, in thisexemplary embodiment, restraining device 10 further comprises a pliablejunction 1000 positioned within the first engaging component 12 andsecond engaging component 16, effectively “splitting” each component,whereby each “split” component is connected to one another by way of aflexible structure 1002. As shown in FIG. 10, flexible structure 1002may comprise a PTFE band or a PTFE mesh, for example, whereby anypotential embodiment of flexible structure 1002, using one or morepliable materials disclosed herein or otherwise known in the art, allowsthe relatively or fully rigid first engaging component 12 and secondengaging component 16 to better fit the stomach, allowing the patient,for example, to bend the stomach when restraining device 10 ispositioned thereon. In addition, and as shown in the exemplaryembodiment in FIG. 10, restraining device 10 may further comprise atissue cover 1004 positioned either partially or fully around either orboth of first engaging component 12 and second engaging component 16.

FIG. 11 shows an exemplary embodiment of a restraining device 10 of thepresent application positioned within a laparoscopic port. As shown inFIG. 11, restraining device 10 is shown as being inserted into a bodyportion by way of laparoscopic port 1100, with the exemplarylaparoscopic port 1100 shown as comprising a ring 1102 and a port sleeve1104 to facilitate introduction of restraining device 10 through anabdominal wall 1106. Viewing the figure from the outside-in, restrainingdevice 10 is shown as being introduced into an abdomen through abdominalwall 1106, with peritoneum 1108 shown as being an innermost layer of theabdominal wall.

An additional embodiment of a restraining device 10 of the disclosure ofthe present application is shown in FIG. 12A. As shown in FIG. 12A,restraining device 10 comprises a first engaging component 12 and asecond engaging component 16, whereby first engaging component 12 andsecond engaging component 16 are coupled to one another by way of one ormore couplers 1200. In this exemplary embodiment, restraining devicecomprises two couplers 1200, shown in further detail in FIG. 12B.Couplers 1200 may comprise coupler arms 1202 connected to one another byway of a coupler bar 1204, and may comprise any number of suitablematerials as described herein for various components of the presentdisclosure. As shown in FIG. 12A, coupler arms 1202 may be positionedwithin first engaging component 12 and second engaging component 16 byway of apertures 1210 (as shown in FIG. 12B) defined therein, allowingfirst engaging component 12 and second engaging component 16 to moverelative to one another as couplers 1200 swivel when positioned at leastpartially within said apertures 1210.

As shown in FIG. 12B, an exemplary embodiment of a coupler 1200 maycomprise a coupler protrusion 1206 at or near the end of each couplerarm 1202, whereby coupler protrusions either prevent or restrict theremoval of coupler 1200 from the either first engaging component 12 orthe second engaging component 16 by way of stops 1208 positioned aboutthe first engaging component 12 and the second engaging component 16 ator near the apertures 1210 defined therein. As coupler 1200 moves in thedirection of the arrow shown in FIG. 12B, coupler protrusions 1206 wouldengage stops 1208, thus preventing or restricting the removal of coupler1200 from the first engaging component 12 and/or the second engagingcomponent 16.

Insertion of the exemplary embodiment of the restraining device 10 shownin FIG. 12A into a body portion may be performed by inserting saidrestraining device 10 through a laparoscopic port with first engagingcomponent 12 and second engaging component 16 either touching or nearlytouching one another, and with couplers 1200 either mostly or fullyinserted within apertures 1210 of restraining device 10. Whenrestraining device has been inserted into a body portion, first engagingcomponent 12 and second engaging component 16 may be separated apre-established distance from one another my way of turning/swivelingcouplers 1200. As such, couplers 1200, as well as first engagingcomponent 12 and second engaging component 16, may be sized and shapedas desired for a particular application,

FIGS. 13A and 13B show an exemplary embodiment of a restraining device10 with a coupler 1200 positioned therein in a configuration to maximizethe interior space 70 between first engaging component 12 and secondengaging component 16. As such, the configuration of coupler 1200 shownin FIG. 12A may be viewed as “closed,” while the configuration shown inFIG. 13A may be viewed as “open.” In addition, and as described aboveand shown in FIG. 13A, coupler 1200 may be withdrawn from apertures offirst engaging component 12 and second engaging component 16 tofacilitate placement of restraining device about an organ of interest,Such withdrawal may be performed using any number of laparoscopic tools,for example, whereby coupler 1200 is withdrawn up to a point whereprotrusions 1206 would engage stops 1208 as shown in FIG. 12B.

Another exemplary embodiment of a restraining device 10 of thedisclosure of the present application is shown in FIGS. 14A and 14B. Asshown in FIGS. 14A and 14B, restraining device 10 comprises a firstengaging component 12 and a second engaging component 16, whereby firstengaging component 12 and second engaging component 16 are coupled toone another by way of one or more couplers 1200. In the embodimentsshown in FIGS. 14A and 14B, couplers 1200 comprise “scissor” couplers1200, whereby at least two coupler bars 1204 are connected to oneanother via a pivot member 1400 so that coupler bars 1204 may pivotabout one another at pivot member 1400. As coupler 1200 shifts from a“closed” configuration, as shown in FIG. 14A, to an “open”configuration, as shown in FIG. 14B, coupler bars 1204 pivot about pivotmember 1400 causing coupler bars 1204 to move closer to one another in adirection opposite the direction of the length of first engagingcomponent 12 and second engaging component 16.

Couplers 1200, as shown in FIGS. 14A and 14B, may “open” and “close” byway of movement of coupler arms 1202 (ends shown in the two figures)within apertures 1210 defined within first engaging component 12 andsecond engaging component 16. Apertures 1210, as shown in theseexemplary embodiments, are configured as horizontal grooves to allowcoupler arms 1202 to move closer to one another within the same aperture1210 while coupler 1200 is “opening” and to allow coupler arms 1202 tomove away from one another within the same aperture 1210 while coupler1200 is “closing.” As shown in FIG. 14B, restraining device 10, in afully open position, would maximize the interior space 70 between firstengaging component 12 and second engaging component 16. Protrusions1402, such as teeth, indentations, and the like, may be positioned at ornear apertures 1210, as shown in FIG. 14B, to facilitate fixation ofcoupler arms 1202 in a desired position, allowing a user positioningrestraining device 10 within a body to measure the exact the interiorspace 70 between first engaging component 12 and second engagingcomponent 16.

Upon insertion of the exemplary embodiment of restraining device 10shown in FIGS. 14A and 14B within an abdominal cavity (through alaparoscopic port, for example), any number of laparoscopic tools may beused to grasp couplers 1200 to withdraw them from first engagingcomponent 12 and second engaging component 16 as referenced hereinregarding various other embodiments of restraining devices 10.

An exemplary delivery apparatus for delivering a restraining device 10of the present application is shown in FIGS. 15A and 15B. As shown inFIG. 15A, an exemplary delivery apparatus 1500 comprises a shaft 1502and arms 1504 at or near a distal end 1506 of shaft 1502. Apparatus 1500may further comprise string 1508, whereby string 1508 may either becoupled to or engaged by a pull bar 1510 (an exemplary “puller” of thepresent disclosure) positioned within the lumen of apparatus 1500. Arms1504 may engage an outer surface of first engaging component 12 andsecond engaging component 16, a protrusion (not shown) extending fromsaid components, or by way of a groove 1512 (shown in FIG. 15B)positioned within said components.

As shown in FIG. 15A, string 1508 is coupled to springs 22 ofrestraining device 10, whereby a “pulling” motion of pull bar mayeffectively pull springs 22 from a first configuration (not shown inFIG. 15A) to a second configuration as shown in FIG. 15A so thatrestraining device may be positioned about an organ of interest. In anadditional embodiment, string 1508 may be positioned at least partiallywithin the lumen of apparatus 1500, whereby a user of apparatus may pullstring 1508 instead of pulling pull bar 1510 to operate apparatus 1500.Various components of apparatus 1500 may comprise any number of suitablematerials, including, but not limited to, the various materialsreferenced herein in connection with components of restraining device10. For example, string 1508 may comprise, for example, plastic or metalthread.

For example, and in an abdominal cavity with the epiplon lessercurvature dissected, arms 1504 of apparatus 1500 may positionrestraining device 10 to a desired location, springs 22 of restrainingdevice 10 may be widely opened, thus separating the first engagingcomponent 12 and the second engaging component 16 by using pull bar 1510to pull the strings 1508 and move springs 22 from an axial position to a90° position relative to first engaging component 12 and the secondengaging component. An “opened” restraining device 10 may then beintroduced through the dissected lesser curvature space in parallelposition to the intragastric mannequin tube, thus creating a desiredpouch size. First engaging component 12 and second engaging component16, upon positioning restraining device 10 about a stomach, would occupythe anterior and posterior wall of the stomach. When the first engagingcomponent 12 and the second engaging component 16 are located in thedesired position, spring 22 approximates the first engaging component 12and the second engaging component 16 to each other gradually withoutproducing any ischemic or tissue damage. Upon moving springs 22 to theirdesired location and/or positioning restraining device 10 about thestomach, restraining device 10 is separated from apparatus 1500, strings1508 are cut and apparatus 1500 is pulled out of the abdominal cavitythrough the port. Restraining device 10 may then be secured in thegastric tissue with superficial stitches.

FIG. 15B shows an exemplary embodiment of at least a portion ofapparatus 1500 engaging a “closed” restraining device 10. As shown inFIG. 15B, arms 1504 of apparatus 1500 are shown engaging first engagingcomponent 12 and second engaging component 16 of restraining device 10by way of grooves 1512 positioned within said components, permittingapparatus 1500 to deliver restraining device 10 through an abdominalport.

FIGS. 16A and 16B show an exemplary embodiment of an apparatus 1500engaging/positioning an exemplary restraining device 10 of thedisclosure of the present application. As shown in FIGS. 16A and 16B,arms 1504 of apparatus 1500 may engage the first engaging component 12and the second engaging component 16 of restraining device 10, wherebythe “opening” of arms 1504 would facilitate the “opening” of restrainingdevice from a “closed” configuration (as shown in FIG. 16A) to an “open”configuration (as shown in FIG. 16B).

“Opening” restraining device 10, as shown in FIG. 16B, may be performedas follows. In the abdominal cavity with the epiplon lesser curvaturedissected, the arms 1504 of apparatus 1500 may be widely opened, thusseparating the first engaging component 12 and the second engagingcomponent 16 of restraining device 10. A surgeon, for example and withthe aid of laparoscopic graspers, may then “pull” out couplers 1200,placing couplers 1200 in a withdrawn configuration as shown in FIG. 16B.Restraining device 10, in an “open” configuration, may be introducedthrough the dissected lesser curvature space in parallel position to theintragastric mannequin tube, thus creating the desired stomach pouchsize. First engaging component 12 and second engaging component 16, whenpositioned about a stomach, would occupy the anterior and posterior wallof the stomach. When the first engaging component 12 and the secondengaging component 16 are located in the desired position, theuser/operator may then approximate the plates to each other gradually(millimetrically) using apparatus 1500 device without producing anyischemic or tissue damage. When the user/operator has positionedrestraining device 10, apparatus 1500 would then be separated fromrestraining device and pulled out of the abdominal cavity through theport. If desired, restraining device may also be secured in the gastrictissue with superficial stitches.

FIGS. 17A and 17B show another exemplary embodiment of an apparatus 1500engaging/positioning an exemplary restraining device 10 of thedisclosure of the present application. As shown in FIGS. 17A and 17B,arms 1504 of apparatus 1500 may engage the first engaging component 12and the second engaging component 16 of restraining device 10, wherebythe use of string 1508 connected to the first engaging component 12 andthe second engaging component 16 may be used by an operator of apparatus1500 to “open” and/or “close” said components. One or more strings 1508,in such exemplary embodiments, may be coupled at their first ends to thefirst engaging component 12 and/or the second engaging component 16, andmay be coupled at their second ends to a string rotator 1700 (anotherexemplary “puller” of the present disclosure) as shown in FIGS. 17A and17B. Operation/rotation of string rotator 1700 may then facilitate the“opening” of restraining device 10 from a “closed” configuration (asshown in FIG. 17A) to an “open” configuration (as shown in FIG. 17B). Insuch an embodiment, arms 1504 may also be positioned upon the firstengaging component 12 and/or the second engaging component 16 at or nearthe center of said components (forming a “pivot” area), and the stringrotator 1700 and strings 1504 affixed thereto may operate to keep saidcomponents in their axial position. Ultimate restraining device 10delivery may be performed using one or more methods described herein.

Restraining device 10 may also be positioned “perpendicularly” usingapparatus 1500 as shown in FIG. 18. As shown in FIG. 18, arms 1504 andstrings 1508 are shown positioned about the first engaging component 12and the second engaging component 16 “perpendicularly” so thatrestraining device 10 and apparatus 1500 are not aligned with oneanother. Rotation of string rotator 1700, as described above, mayfacilitate the opening and/or closing of restraining device 10.

The various embodiments of restraining devices 10 of the presentdisclosure may be introduced into a body cavity through, for example, alaparoscopic port. Such restraining devices 10 would be inserted while“compressed” (as shown in FIGS. 1, 7A, 10, 11, 12A, and 14A, forexample), and when inserted, would be “opened” or “deployed” (as shownin FIGS. 2, 7B, 8, 9, 13A, 13B, and 14B, for example) prior to beingpositioned about a stomach 100. In addition, a user of such arestraining device 10 may adjust the opening/deployed dimensions ofrestraining device 10 prior to positioning it about a stomach, and mayfurther tailor the open/deployed dimensions of restraining device 10after it has been positioned as desired.

Furthermore, any number of exemplary embodiments of restraining devices10 of the present application may be wholly or partially resorbable bythe body. For example, and using the exemplary restraining device 10shown in FIGS. 1 and 2 as an example, first and second engagingcomponents 12, 16 may not be resorbable by the body, while springs 22may be resorbable. In such an embodiment, restraining device 10, oncepositioned about a stomach 100, may slowly begin the process of total orpartial resorption. Resorbable materials suitable for one or moreportions of restraining devices 10 may include, but are not limited to,polyglycolide (PGA), polylactide (PLA), 1-lactide (LPLA),poly(dl-lactide) (DLPLA), poly(ε-caprolactone) (PCL), poly(dioxanone)(PDO), polylglycolide-trimethylene carbonate (PGA-TMC),poly(d,l-lactide-co-glycolide) (DLPLG), or combinations thereof.

In a situation where it is desired to have restraining device 10 serveas a reversible bariatric device, and if it is desired not to engage ina subsequent procedure to, for example, laparoscopically remove some orall of restraining device 10 from a body, some or all of restrainingdevice 10 may be resorbed. By way of example, an exemplary restrainingdevice comprising resorbable springs 22 may be positioned about astomach, and first and second engaging components 12, 16 may slowlybecome coated with various fibrotic tissue. As springs 22 resorb,springs 22 will eventually no longer operate to connect first and secondengaging components 12, 16 to one another, which will effectively causethe various portions of restraining device 10 to no longer serve as arestraining mechanism. Springs 22 may also become coated, in part or intheir entirety, by fibrotic tissue, so that when springs 22 resorb,first and second engaging components 12, 16 remain positioned aboutstomach 100, but the introduction of food into a stomach 100, forexample, does not exert any pressure on springs 22 by way of first andsecond engaging components 12, 16 as first and second engagingcomponents 12, 16 are no longer connected to one another by way ofsprings 22. Furthermore, first and second engaging components 12, 16 maybe resorbable and springs 22 may not, so as first and second engagingcomponents 12, 16 resorb within the body, springs 22 no longer serve toconnect first and second engaging components 12, 16 to each other, andrestraining device 10 no longer performs any restraining function.Additional embodiments of restraining devices 10 may be resorbable,including, but not limited to, struts 700 and mesh curtain 702.

Regarding removal of exemplary embodiments of restraining devices 10 ofthe present application, said restraining devices 10 may be removed inwhole or in part, for example, by way of a laparoscopic procedure.Reversibility of restraining devices 10, as referenced in the presentapplication, pertains to the ability to position a restraining device 10about a tissue or organ, and at some time thereafter, have some or allof restraining device 10 resorb within a body or remove some or all ofrestraining device from the body so that restraining device 10 no longerfunctions to restrain a tissue or organ. For example, and referencingthe exemplary embodiments shown in FIGS. 1 and 2, a laparoscopicprocedure to remove springs 22 from the restraining device 10 and thebody, but not to remove first and second engaging components 12, 16 fromthe body, would have the effect of “reversing” the procedure of placingsaid restraining device 10 about a tissue or organ. Similarly, and asshown in FIGS. 7A, 7B, and 8, removal of struts 700 from restrainingdevice 10 would also have the effect of “reversing” the placement ofrestraining device 10 about a tissue or organ.

Furthermore, and if desired, the entirety of restraining device 10 maybe removed laparoscopically by, for example, reversing the steps used toinsert said restraining device 10 within a body. For example, a method1900 for removing a restraining device 10 from a body as shown in FIG.19 may comprise the steps of withdrawing restraining device 10 from atissue or organ (withdrawal step 1904), configuring restraining device10 to fit within a laparoscopic port (configuration step 1906), andremoving restraining device 10 from the body through a laparoscopic port(removal step 1908). Such an exemplary method may be preceded bypositioning a laparoscopic port within a body to facilitate removal ofrestraining device 10 (port insertion step 1902), and may be followed byremoving said laparoscopic port from the body after removal step 1908(port removal step 1910).

Additional embodiments of restraining devices 10 of the presentdisclosure are shown in FIGS. 20 and 23. As shown in the embodimentsshown in FIGS. 20 and 23, restraining devices 10 comprise a firstengaging component 12 and a second engaging component 16, such as thoseprovided in various other embodiments herein. First engaging component12 and second engaging component 16, in such an exemplary embodiment,are positioned relatively parallel to one another. A first swivel arm2000 and a second swivel arm 2002 are pivotally connected to firstengaging component 12 and second engaging component 16, so that firstswivel arm 2000 engages first engaging component 12 at pivot point 2004and engages second engaging component 16 at pivot point 2006, and sothat second swivel arm 2002 engages first engaging component 12 at pivotpoint 2008 and engages second engaging component 16 at pivot point 2010.First swivel arm 2000 and second swivel arm 2002 may swivel in thedirections shown in arrows A and B in FIGS. 20 and 23, noting that firstswivel arm 2000 and second swivel arm 2002 may move in oppositedirections, so that one moves in the direction of arrow A and the othermoves in the direction of arrow B, or first swivel arm 2000 and secondswivel arm 2002 may move in the same direction.

First engaging component 12 and/or second engaging component 16 maypresent studs 2012, as shown in FIGS. 20 and 23, whereby studs 2012permit first swivel arm 2000 and/or second swivel arm 2002 to be engagedthereto and permit swiveling/rotation about the various pivot points. Inat least one embodiment, studs 2012 have a bulbous component relativelylarger than a non-bulbous portion, so that a first swivel arm 2000and/or a second swivel arm 2002 presenting one or more apertures 2014therethrough may engage studs 2012. Any number of other means to couplefirst swivel arm 2000 and/or second swivel arm 2002 to first engagingcomponent 12 and/or second engaging component 16 may be used, such aspins, rivets, snaps, screws, and/or other fasteners or coupling means.

First swivel arm 2000 and second swivel arm 2002, as shown in FIGS. 20and 23, may further comprise a first interconnection arm 2016 and asecond interconnection arm 2018 positioned relative to bends 2020, 2022of said arms. Bends 2020, 2022, as shown in FIGS. 20 and 23, arepositioned in the relative middle (somewhere between the relative ends)of first swivel arm 2000 and a second swivel arm 2002, so that firstswivel arm 2000 and second swivel arm 2002 form a relative “U-shape”within restraining device 10. First swivel arm 2000 and/or a secondswivel arm 2002 may further comprise various additional curvatures 2024,such as shown in FIG. 20, such that bends 2020, 2022 and/or curvatures2024 define a native U-shaped configuration as previously described.

An interior space 70 between the first engaging component 12 and thesecond engaging components 16, as shown in FIGS. 20 and 23, may changedepending on various factors and/or configurations of restraining device10. For example, and during insertion of an embodiment of a restrainingdevice 10 such as shown in FIG. 20 or 23 through a laparoscopic port,first swivel arm 2000 and a second swivel arm 2002 may be relativelyparallel to, or in the same relative plane as, first engaging component12 and second engaging component 16, so that the interior space 70 isrelatively small. After insertion, and after swiveling first swivel arm2000 and a second swivel arm 2002 about first engaging component 12 andsecond engaging components 16, the interior space 70 may either stay thesame or increase to facilitate placement of restraining device 10 abouta stomach, for example. Furthermore, the use of a tape 2026 positionedabout one or more of the first swivel arm 2000 and the second swivel arm2002, as shown in FIG. 20, may further adjust the amount of interiorspace 70 between the first engaging component 12 and the second engagingcomponents 16 depending on the amount of relative tension (pull) isapplied to tape 2026. For example, if tape 2026 is positioned about oneor more of the first swivel arm 2000, and the second swivel arm 2002 sothat pulling tape 2026 in a direction shown by arrow C in FIG. 20 causesportions of tape 2026 to press against first interconnection arm 2016and/or second interconnection arm 2018 causing the relative ends of eachof first swivel arm 2000 and a second swivel arm 2002 to move towardeach other, the amount of interior space 70 between first engagingcomponent 12 and second engaging component 16 may be reduced. In such anembodiment, restraining device 10 could be inserted into a mammalianbody, positioned around a bodily organ without applying pressure to saidorgan, and tape 2026 could be pulled so that the amount of interiorspace 70 is adjusted as desired for the particular application. In abariatric application, for example, it is desired not to have portionsof restrictive device 10 apply any pressure about the stomach, but tape2026 could be pulled/adjusted so first engaging component 12 and secondengaging component 16 properly engage the stomach and be sutured theretoas desired. Distention of the stomach, such as by the introduction ofsolid and/or liquid food or water into the stomach, would cause thestomach to exert a force/pressure against the first engaging component12 and second engaging component 16, forming a first stomach portion 110and a second stomach portion 112 as shown in FIGS. 4A and 4B referencedabove and FIG. 21 referenced below.

In addition, and as shown in the exemplary embodiments of restrainingdevices 10 of the present disclosure shown in FIGS. 20 and 23, variousportions of restraining device 10, such as the first engaging component12, the second engaging component 16, the first swivel arm 2000, and/orthe second swivel arm 2002 may have one or more suture apertures 32defined therethrough to facilitate the placement of one or more sutures34 (also referred to herein as strings 34) to couple restraining device10 to a portion of a mammalian body, such as a stomach. In variousembodiments, one or more of the relative ends of the first engagingcomponent 12 and the second engaging component 16 may be rounded and/ortapered to improve overall patient comfort when a restraining device ispositioned within the patient's body.

FIG. 21 shows an exemplary embodiment of a restraining device 10, suchas shown in FIG. 20, positioned about a stomach. As shown in FIG. 21,device 10 may be positioned about stomach 100 similar to placement ofrestraining device 10 about stomach 100 as shown in FIG. 5B, so that thefirst engaging component 12 and the second engaging component 16 (notshown in FIG. 21) may engage opposite sides of stomach 100. Restrainingdevice 10 may be secured to stomach 100 using one or more sutures 34 tocouple restraining device 10 to stomach 100, and restraining device 100may be further positioned about stomach 100 by way of adjusting tape2026 positioned around restraining device 10. As shown in FIG. 21, tape2026 is positioned about restraining device 10 so to engage firstinterconnection arm 2016 and second interconnection arm 2018, wherebypulling tape 2026 in a direction shown by arrow C would cause firstengaging component 12 and second engaging component 16 to move closer toone another. Tape 2026 may have one or more detectable portions 2100positioned/imprinted thereon, so that a user of restraining device 10can “see” the adjustment of tape 2026 by way of fluoroscopy (ifdetectable portions 2100 are radioopaque), camera, or other meanswhereby portions of a device positioned within a body can be visualized,either directly or through some sort of technological means, to allow auser of such a device to adjust the same.

Furthermore, and as shown in FIG. 21, restraining device 10 may have acover flap 2012 positioned thereon to assist maintaining the placementof restraining device 10 about stomach 100. Cover flap 2012, as shown inFIG. 21, may be ultimately coupled to first engaging component 12 andsecond engaging component 16 (not shown in FIG. 21), so that afterrestraining device 10 is positioned about a stomach 100, cover flap 2012may be closed (initially secured to first engaging component 12 andclosed by way of securing cover flap 2012 to second engaging component16, or vice versa) about an upper portion of stomach 100.

As referenced above, restraining device 10 is positioned about stomach100 so not to exert pressure upon stomach 100, but when stomach 100becomes distended, stomach 100 exerts pressure/force upon first engagingcomponent 12 and second engaging component 16 of restraining device 10.

Steps of a method for delivering and positioning an embodiment of arestraining device 10, such as the embodiment shown in FIGS. 20 and 21,are shown in FIG. 22. As shown in FIG. 22, exemplary method 2200comprises the step of laparascopically inserting/advancing restrainingdevice 10 into a patient's body (an exemplary insertion step 2202). Inat least one embodiment, the restraining device 10 may be insertedthrough a 15 millimeter cannula under insufflation into the appropriatecavity of the patient's body. This may be achieved through use of anexemplary delivery device known in the art. At step 2202, first swivelarm 2000 and second swivel arm 2002 of restraining device 10 areswiveled/positioned in the substantially parallel position such that theoverall diameter of the restraining device 10 is sufficiently narrow forinsertion into the body.

At step 2204, restraining device 10 is advanced to a location adjacentto a targeted tissue, such as a stomach 100 (an exemplary advancementstep 2204). At step 2206 (an exemplary swivel step), first swivel arm2000 and second swivel arm 2002 of restraining device 10 are swiveledfrom a substantially parallel position to a substantially perpendicularposition, separating the first and second engaging components 12, 16from one another to a native interior space 70. Step 2206 may beperformed using any number of standard laparoscopic tools known in theart useful to pull and grasp portions of a tissue or a device. In thismanner, neither the proximal ends 13, 17 nor distal ends 14, 18 of thefirst and second engaging components 12, 16 of restraining device 10 areblocked by first swivel arm 2000 and second swivel arm 2002, and thefirst and second engaging components 12, 16 may be advanced over atargeted tissue, such as a stomach 100.

At step 2208, and under fluoroscopy, direct camera control or otherwise,restraining device 10 is positioned over the targeted tissue (anexemplary positioning step). In at least one embodiment, and at step2206, the first side 12A of the first engaging component 12 ispositioned adjacent to the desired surface of the targeted tissue andthe first side 16A of the second engaging component 16 is positionedadjacent to an opposite side of the targeted tissue. As the first andsecond engaging components 12, 16 of the restraining device 10 arepositioned adjacent to opposite sides of the targeted tissue, at thisstep 2208 the targeted tissue is positioned within the interior space 70formed between the first and second engaging components 12, 16. Further,due to the configuration and composition of restraining device 10,restraining device 10 can remain within the patient's body for as longas the restoration or support treatment delivered thereby is desired.

After restraining device 10 is positioned about a targeted tissue (byway of performing positioning step 2208), method 2200 may furthercomprise the optional steps of securing one or more sutures to connectrestraining device 10 to the targeted tissue (an exemplary suturing step2210), and may further comprise the step of securing cover flap 2012 tofurther secure restraining device about the targeted tissue (anexemplary cover flap step 2212). In addition, and as shown in FIG. 22,method 2200 may further comprise the step of adjusting tape 2026 tocontrol/adjust the interior space 70 between the first engagingcomponent 12 and the second engaging component 16 whereby at least aportion of the targeted tissue is positioned therebetween (an exemplarytape adjustment step 2214).

In the exemplary embodiment of a restraining device 10, as shown in FIG.23, restraining device 10 comprises one or more adjustment rods 2300coupled to the first swivel arm 2000 and the second swivel arm 2002. Inthe embodiment shown in FIG. 23, for example, adjustment rods 2300 arecoupled to first swivel arm 2000 and second swivel arm 2002 at or nearbends 2020, 2022, and are further coupled to a first interconnection arm2016 and a second interconnection arm 2018, respectively. As shown inFIG. 23, at in at least one embodiment, adjustment rods 2300 are coupledto first swivel arm 2000 and second swivel arm 2002 through swivel armapertures 2302 defined therethrough, and are further coupled to firstinterconnection arm 2016 and second interconnection arm 2018 throughinterconnection arm apertures 2304 defined therethrough.

Adjustment rods 2300, as shown in FIGS. 23 and 25, further comprise abar 2306 coupled to adjustment rods 2300 at or near a distal end 2308 ofadjustment rod 2300. Bar 2306, as shown in FIG. 24, is positioned distalto first interconnection arm 2016/second interconnection arm 2018, sothat adjustment of a dial 2310 coupled to adjustment rod 2300 causesmovement of first engaging component 12 and second engaging component 16toward or away from one another. As shown in FIG. 24, firstinterconnection arm 2016 and second interconnection arm 2018, in variousembodiments, may extend either completely or substantially along thelength of first swivel arm 2000 and second swivel arm 2002 distal tofirst interconnection arm 2016 and second interconnection arm 2018, sothat adjustment of dial 2310 facilitates movement of first swivel arm2000 and second swivel arm 2002, thus facilitating movement of firstengaging component 12 and second engaging component 16.

As shown in FIGS. 23-25, adjustment rod 2300 may further comprise a cap2312 coupled thereto at or near a proximal end 2314 of adjustment rod2300. Cap 2312, as shown in FIGS. 23-25, may prevent dial 2310 fromdisengaging adjustment rod 2300 so that when restraining device 10 ispositioned within a body, dial 2310 remains upon restraining device 10.Cap 2312, in at least one embodiment, may be bulbous/rounded at one endfor comfort when restraining device 10 is positioned within a body.

As shown in FIG. 24, dial 2310 may facilitate adjustment of device 10 byway of threads 2316 positioned along adjustment rod 2300. In such anembodiment, rotation of dial 2310 in a first direction would cause firstengaging component 12 and second engaging component 16 to move towardone another, and rotation of dial 2310 in a second/opposite directionwould cause first engaging component 12 and second engaging component 16to move away from one another. As such, restraining device 10 may bepositioned within a body about a stomach, for example, and be adjustedusing dial 2310 so that restraining device 10 is optimally positionedabout the stomach.

As shown in the exemplary embodiments in FIGS. 25 and 26, dial 2310 maydefine a dial aperture 2318, whereby indicia 2320 upon adjustment rod2300 may be viewed therethrough. As shown in FIG. 26, for example, asdial 2310 is rotated, one or more indicia 2320 may be visible throughdial aperture 2318, so that a user of such an embodiment of arestraining device 10 of the present disclosure may identify a level ofadjustment. Indicia 2320 may be one or more numbers, letters, linesand/or other indicia 2320 useful to identify a level of adjustment ofrestraining device 10.

As shown in FIG. 27, and in at least one embodiment of a restrainingdevice 10 of the present disclosure, restraining device 10 furthercomprises at least one flange 2700 coupled to first swivel arm 2000and/or second swivel arm 2002. Flange 2700 defines an aperturetherethrough so that adjustment rod 2300 may fit therethrough, providingphysical support for dial 2310 as dial 2310 engages said flange 2700.

An exemplary embodiment of a restraining device 10 of the presentdisclosure having adjustment rods 2300 is shown in FIG. 28. As shown inFIG. 28, first engaging component 12 and/or second engaging component 16may define one or more facets 2800 along at least part of the length ofsaid components 12, 16, whereby facets 2800 provide a generally arcuateprofile as shown therein. Facets 2800 may further improve the overallcomfort of restraining device 10 when it is positioned with a patient'sbody.

Steps of a method for delivering and positioning an embodiment of arestraining device 10, such as the embodiment shown in FIG. 23, areshown in FIG. 29. As shown in FIG. 29, exemplary method 2900 comprisesthe step of laparascopically inserting/advancing restraining device 10into a patient's body (an exemplary insertion step 2202) as previouslydiscussed herein. At step 2202, first swivel arm 2000 and second swivelarm 2002 of restraining device 10 are swiveled/positioned in thesubstantially parallel position such that the overall diameter of therestraining device 10 is sufficiently narrow for insertion into thebody.

At step 2204, restraining device 10 is advanced to a location adjacentto a targeted tissue, such as a stomach 100 (an exemplary advancementstep 2204). At step 2206 (an exemplary swivel step), first swivel arm2000 and second swivel arm 2002 of restraining device 10 are swiveledfrom a substantially parallel position to a substantially perpendicularposition, separating the first and second engaging components 12, 16from one another to a native interior space 70 as previously discussedherein.

At step 2208, and under fluoroscopy, direct camera control or otherwise,restraining device 10 is positioned over the targeted tissue (anexemplary positioning step) as previously referenced herein. Afterrestraining device 10 is positioned about a targeted tissue (by way ofperforming positioning step 2208), method 2900 may further comprise theoptional steps of securing one or more sutures to connect restrainingdevice 10 to the targeted tissue (an exemplary suturing step 2210), andregarding an embodiment of restraining device 10 of the presentdisclosure comprising a cover flap 2012, method 2900 may furthercomprise the step of securing cover flap 2012 to further securerestraining device about the targeted tissue (an exemplary cover flapstep 2212). In addition, and as shown in FIG. 29, method 2900 mayfurther comprise the optional step of rotating dial 2310 tocontrol/adjust the interior space 70 between the first engagingcomponent 12 and the second engaging component 16 whereby at least aportion of the targeted tissue is positioned therebetween (an exemplarydial adjustment step 2902).

An additional embodiment of a restraining device 10 of the presentdisclosure is shown in FIGS. 30 and 31. As shown in FIGS. 30 and 31,restraining devices 10 each comprise a first engaging component 12 and asecond engaging component 16, such as those provided in various otherembodiments herein. First engaging component 12 and second engagingcomponent 16, in such exemplary embodiments, are positioned relativelyparallel to one another. A first swivel arm 2000 and a second swivel arm2002 are pivotally connected to first engaging component 12 and secondengaging component 16, so that first swivel arm 2000 engages firstengaging component 12 at pivot point 2004 and engages second engagingcomponent 16 at pivot point 2006, and so that second swivel arm 2002engages first engaging component 12 at pivot point 2008 and engagessecond engaging component 16 at pivot point 2010. First swivel arm 2000and second swivel arm 2002 may swivel in the directions shown in arrowsA and B in FIGS. 30 and 31, noting that first swivel arm 2000 and secondswivel arm 2002 may move in opposite directions, so that one moves inthe direction of arrow A and the other moves in the direction of arrowB.

As shown in FIGS. 30 and 31, first swivel arm 2000 may comprise a firstarm member 3000 and a second arm member 3002, and second swivel arm 2002may comprise a first arm member 3020 and a second arm member 3022. Firstarm members 3000, 3020 and second arm members 3002, 3022 may each coupleto a hub 3004, 3024 as shown in FIGS. 30 and 31. In at least oneembodiment, and as shown in FIGS. 30 and 31, second arm members 3002,3022 may be fixedly coupled to hubs 3004, 3024, and first arm members3000, 3020 may slidingly engage said hubs 3004, 3024, whereby portionsof first arm members 3000, 3020 are positioned between hubs 3004, 3024and hub brackets 3006, 3026. First arm members 3000, 3020 may each haveat least one bend 3008, 3028 therein, as shown in FIGS. 30 and 31, tofacilitate said engagement of first arm members 3000, 3020 to hubs 3004,3024. First arm members 3000, 3020, in at least one embodiment, arecapable of movement relative to hubs 3004, 3024 in the directions shownin arrows C and D in FIGS. 30 and 31, whereby first arm members 3000,3020 move in a first direction until they contact hubs 3004, 3024, forexample, and move in a second direction until arm flanges 3010, 3030 offirst arm members 3000, 3020 contact hub brackets 3006, 3026, forexample. First arm members 3000, 3020 and second arm members 3002, 3022may be referred to as “fixed arms” if they are fixed to one of hubs3004, 3024, and may be referred to as “expandable arms” if they arecoupled to hubs 3004, 3024 by way of hub brackets 3006, 3026 tofacilitate movement relative thereto.

In at least one embodiment of an exemplary restraining device 10 of thepresent disclosure, and as shown in FIGS. 30 and 31, hub brackets 3006,3026 may be coupled to hubs 3004, 3024 by way of one or more fasteners3012, such as one or more screws, pins, rivets, and the like. Similarly,second arm members 3002, 3022 may be coupled to hubs 3004, 3024 by wayof one or more fasteners 3012. In at least one embodiment, first armmembers 3000, 3020 and/or second arm members 3002, 3022 are comprised ofstainless steel (such as 316LVM, or implant-grade stainless steel) hubs3004, 3024 are comprised of one or more polyaryletherketones (PEEKs),and hub brackets 3006, 3026 are also comprised of stainless steel. Firstengaging component 12 and second engaging component 16 may, in at leastone embodiment, comprise stainless steel which may then becoated/overmolded with a biocompatible polymer, such as polyurethane(PX205, for example) or tecothane (TT-1075D-M, for example).

In various embodiments of restraining devices 10 of the presentdisclosure, restraining devices 10 may comprise one or more pads 3014,3034 coupled to first arm members 3000, 3020 and/or second arm members3002, 3022. Said pads 3014, 3034 may comprise any number ofbiocompatible polymers and/or other materials that are suitable forcontacting an organ, such as a stomach, and which may provide some sortof cushioning effect. In at least one embodiment, pads 3014, 3034 may becomprised of a biocompatible polymer such as carbothane (such asPC-3595A), for example, and may be coupled to first arm members 3000,3020 and/or second arm members 3002, 3022 using one or more fasteners3012. In at least one embodiment, fasteners 3012, as referenced herein,may be comprised of stainless steel.

Regarding the exemplary embodiment of restraining device 10 shown inFIGS. 30 and 31, restraining device is shown in an open configuration inFIG. 30 and in a closed configuration in FIG. 31. As shown in FIG. 31,an exemplary restraining device 10 of the present disclosure maycomprise a strap 3100 coupled thereto at first engaging component 12 andsecond engaging component 16. In at least one embodiment, strap 3100 isfixedly coupled to one or both of first engaging component 12 and secondengaging component 16, and in another embodiment, strap is removablycoupled to one or both of first engaging component 12 and secondengaging component 16 by way of one or more sutures 32 (such as a 2-0silk suture, for example), as shown in FIG. 31. As shown in theembodiment of restraining device 10 in FIG. 31, a first end 3102 ofstrap 3100 is fixedly coupled to second engaging component 16, and asecond end 3104 of strap 3100 is removably coupled to first engagingcomponent 12 by way of suture 32. In practice, suture 32 may not bepositioned within suture aperture(s) 34 defined within one or morecomponents of restraining device 10 until after restraining device 10has been inserted into a mammalian body. In at least one embodiment, oneor more suture apertures 34 defined within one or more components ofrestraining device 10 may comprise/define one or more eyelets 3106,whereby said eyelets 3106 provide additional reinforcement/strength, andmay also provide a more smooth, rounded contour than suture apertures 34so not to cause unintended wear, and potential breakage, of one or moresutures 32 positioned therethrough. In at least one embodiment, strap3100 comprises carbothane (PC-3595A), and eyelets 3106 are comprised ofnickel. In at least another embodiment, strap 3100, or portions thereof,may be radiopaque.

FIGS. 32 and 33 show top views of exemplary restraining devices 10 ofthe present disclosure. As shown in FIG. 32, restraining device 10 isshown with first swivel arm 2000 and second swivel arm 2002 in apositioned whereby said arms 2000, 2002 are at least substantiallyperpendicular to first engaging component 12. As shown in FIG. 32, andin at least one embodiment of a restraining device 10 of the presentdisclosure, first swivel arm 2000 is relatively shorter than secondswivel arm 2002, whereby such a configuration allows for placement ofrestraining device 10 about a stomach, for example, as shown in FIGS.40, 41, and 42.

FIG. 33 shows an exemplary restraining device 10 whereby first swivelarm 2000 and second swivel arm 2002 share a common linear axis withfirst engaging component 12. In the configuration shown in FIG. 33, forexample, restraining device 10 may fit within a bodily laparoscopic portfor eventual swiveling of arms 2000, 2002 and placement of restrainingdevice 10 about an organ. FIG. 34 shows a front view of an exemplaryrestraining device 10 of the present disclosure in a similarconfiguration as shown in FIG. 33, and FIG. 35 shows a perspective viewof restraining device 10 in the same configuration.

FIGS. 36 and 37 show a side view and a perspective view, respectively,of an exemplary first swivel arm 2000 of the present disclosure. In atleast one embodiment, and as shown in FIG. 36, first swivel arm 2000 hasan interior length (as indicated by arrow A in the figure) of about 26.5mm, and has an expanded interior height (as indicated by arrow B in thefigure) of about 19.1 mm. In other embodiments, the interior length andinterior height may be greater or lesser than those shown in the figure.

As shown in FIGS. 36 and 37, an exemplary first swivel arm 2000 may haveone or more distal arm flanges 3600, which, in at least one embodiment,are bent relatively down/up and then out, as shown in the figures, sothat exemplary first swivel arm 2000 may engage first engaging component12 and second engaging component 16 while maintaining integrity of firstswivel arm 2000 and/or providing additional clearance for an organpositioned therebetween. In at least one embodiment, and as shown inFIG. 36, distal arm flanges 3600 result in an expanded flange height (asindicated by arrow C in the figure) of less than the expanded interiorheight. The relative distal ends of first swivel arm 2000, which maythemselves comprise distal arm flanges 3600, may comprise one or morearm apertures 3602 configured to receive, for example, one or morerivets 3604 (as shown in FIGS. 30 and 31) therethrough to couple firstswivel arm 2000 to a first engaging component 12 and a second engagingcomponent 16. In at least one embodiment, rivets 3604 are comprised ofstainless steel. In at least another embodiment, another type offastener 3012, as described herein, aside from a rivet 3604 may be used.

FIGS. 38 and 39 show a side view and a perspective view, respectively,of an exemplary second swivel arm 2002 of the present disclosure. In atleast one embodiment, and as shown in FIG. 38, second swivel arm 2002has an interior length (as indicated by arrow A in the figure) of about37 mm, and has an expanded interior height (as indicated by arrow B inthe figure) of about 18 mm. In other embodiments, the interior lengthand interior height may be greater or lesser than those shown in thefigure.

As shown in FIGS. 38 and 39, an exemplary second swivel arm 2002 mayalso have one or more distal arm flanges 3600, which, in at least oneembodiment, are bent relatively down/up and then out, as shown in thefigures, so that exemplary second swivel arm 2002 may engage firstengaging component 12 and second engaging component 16 while maintainingintegrity of second swivel arm 2002 and/or providing additionalclearance for an organ positioned therebetween. In at least oneembodiment, and as shown in FIG. 38, distal arm flanges 3600 result inan expanded flange height (as indicated by arrow C in the figure) ofless than the expanded interior height. The relative distal ends ofsecond swivel arm 2002, which may themselves comprise distal arm flanges3600, may comprise one or more arm apertures 3602 configured to receive,for example, one or more rivets 3604 (as shown in FIGS. 30 and 31)therethrough to couple second swivel arm 2002 to a first engagingcomponent 12 and a second engaging component 16.

FIG. 40 shows an exemplary embodiment of a restraining device 10, suchas shown in FIGS. 30 and 31, positioned about a stomach. As shown inFIG. 40, device 10 may be positioned about stomach 100 similar toplacement of restraining device 10 about stomach 100 as shown in FIGS.5B and 21, for example, so that the first engaging component 12 (notshown in FIG. 40) and the second engaging component 16 may engageopposite sides of stomach 100. Restraining device 10 may be secured tostomach 100 using one or more sutures 34 to couple restraining device 10to stomach 100, or one or more sutures 34 may be positioned withinsuture aperture(s) 34 within strap 3100 and one or both of firstengaging first engaging component 12 and second engaging component 16 tosecure restraining device 100 about a stomach 100. FIGS. 41 and 42 showadditional views of an exemplary restraining device 10 positioned abouta stomach 100.

The various embodiments of restraining devices 10 described hereinprovide numerous benefits over the devices and systems of the prior art.An exemplary restraining device 10 may be inserted laparoscopicallyand/or endoscopically, is minimally invasive, completely reversible andavailable for chronic placement without the risk of complications.Furthermore, use of a restraining device 10 to treat and/or support atargeted tissue or organ produces a reduced amount of negative sideeffects than the procedures of the prior art for similar indications.While embodiments of restraining devices 10 are presented with respectto specific anatomy and treatment examples, the various restrainingdevices 10 and methods 300 may be expanded for use in treating anyorgan, limb or body structure that would benefit from reshaping,restoring, or added support provided through a reversible, easy to useand easy to implement technique for chronic placement.

Prior art focuses on creating a restrictive line through “clamps” tomimic the gastric sleeve. The disclosure of the present applicationprovides various loosely-fitting restraints (to prevent migration) andto affect motility of the stomach. The contractility or motility curveof the gastric tissue is substantially attenuated by an externalrestraint (as discussed below), thus affecting the movement of bolusthrough the stomach. Hence, the food volume will remain in the pouchlonger and lead to earlier distension which affects neuroactivity andmechanosensory elements of satiety. Hence, the principle of therestraining devices 10 of the present disclosure is based on flow(motility) unlike previous art that focuses on restrictive which risksmigration and erosion.

As described herein, placement of exemplary restraining devices 10through the lower curvature can be easily implemented as opposed toprocedures which approach the greater curvature where the liver anddiaphragm are in the proximity. Furthermore, various clips, clamps, orperforated plates known in the art which transverse the stomach (asopposed to sleeve) can lead to substantial remodeling of the funduswhich would lead to weight regain after a period of time. As such, thevarious connectors of the disclosure of the present application operateto prevent overall stretch of stomach and hence prevent remodeling. Thestretch that leads to mechanosensory satiety in the restraining devicesof the present disclosure occurs locally between the restraining springsor bars while still restraining the overall pouch. No such globalcontainment of the gastric tissue is known in the prior art. Finally,various clips, clamps, or perforated plates known in the art would exertsignificant local stresses on the tissue which can lead to erosion ormigration as the substantially restricted stomach would attempt todistend. Conversely, the first engaging component 12 and the secondengaging component 16 of the restraining devices 10 of the presentdisclosure distribute the stress more uniformly over the plate and onlyrestrain a relatively small pouch rather than a more substantial portionof the stomach transversely.

While various embodiments of implantable restraining devices, systems,and methods for using the same have been described in considerabledetail herein, the embodiments are merely offered by way of non-limitingexamples of the disclosure described herein. It will therefore beunderstood that various changes and modifications may be made, andequivalents may be substituted for elements thereof, without departingfrom the scope of the disclosure. Indeed, this disclosure is notintended to be exhaustive or to limit the scope of the disclosure.

Further, in describing representative embodiments, the disclosure mayhave presented a method and/or process as a particular sequence ofsteps. However, to the extent that the method or process does not relyon the particular order of steps set forth herein, the method or processshould not be limited to the particular sequence of steps described.Other sequences of steps may be possible. Therefore, the particularorder of the steps disclosed herein should not be construed aslimitations of the present disclosure. In addition, disclosure directedto a method and/or process should not be limited to the performance oftheir steps in the order written. Such sequences may be varied and stillremain within the scope of the present disclosure.

1. An implantable restraining device, comprising: a first engagingcomponent and a second engaging component at least substantiallyparallel to one another; a first swivel arm, comprising: a first fixedarm, a first expandable arm, and a first hub, wherein the first fixedarm is pivotally connected to the first engaging component at or near afirst fixed arm first end and is coupled to the first hub at or near afirst fixed arm second end, and wherein the first expandable arm ispivotally connected to the second engaging component at or near a firstexpandable arm first end and is connected to the first hub at or near afirst expandable arm second end by way of a first hub bracket; a secondswivel arm, comprising: a second fixed arm, a second expandable arm, anda second hub, wherein the second fixed arm is pivotally connected to thefirst engaging component at or near a second fixed arm first end and iscoupled to the second hub at or near a second fixed arm second end, andwherein the second expandable arm is pivotally connected to the secondengaging component at or near a second expandable arm first end and isconnected to the second hub at or near a second expandable arm secondend by way of a second hub bracket; and wherein the first expandable armand the second expandable are capable of movement relative to the firsthub and the second hub respectively so that a distance between the firstengaging component and the second engaging component may change relativeto movement of the first expandable arm and the second expandable arm.2. The device of claim 1, wherein the first swivel arm is capable ofrotation in a first direction, and wherein the second swivel arm iscapable of rotation in an opposing second direction.
 3. The device ofclaim 2, wherein the first swivel arm and the second swivel arm arecapable of rotation so that the first swivel arm, the second swivel arm,the first engaging component, and the second engaging component share acommon linear axis,
 4. The device of claim 2, wherein the first swivelarm and the second swivel arm are capable of rotation so that the firstswivel arm and the second swivel arm are substantially or fullyperpendicular to the first engaging component and the second engagingcomponent,
 5. The device of claim 1, wherein the first fixed arm isrelatively shorter than the second fixed arm, and wherein the firstexpandable arm is relatively shorter than the second expandable arm. 6.The device of claim 1, further comprising: a first arm flange at or nearthe first expandable arm second end, the first arm flange configured tolimit expansion of the first expandable arm relative to the first fixedarm; and a second arm flange at or near the second expandable arm secondend, the second arm flange configured to limit expansion of the secondexpandable arm relative to the second fixed arm.
 7. The device of claim1, wherein the device is sized and shaped to fit within a laparoscopicbodily port.
 8. The device of claim 1, further comprising: a first strappositioned at a first end of the first engaging component and at a firstend of the second engaging component, the first strap configured tolimit movement of the first engaging component and the second engagingcomponent when the first strap is coupled to the first engagingcomponent and the second engaging component.
 9. The device of claim 8,wherein the first strap is fixedly coupled to one of the first end ofthe first engaging component or the first end of the second engagingcomponent.
 10. The device of claim 9, wherein the first strap is coupledto one of the first end of the first engaging component or the first endof the second engaging component by way of at least one suture.
 11. Thedevice of claim 8, wherein the first strap has at least one sutureaperture defined therethrough, and wherein at least one of the firstengaging component and the second engaging component has at least oneplate aperture defined therethrough, the at least one suture apertureand the at least one plate aperture configured to permit a suture to beplaced therethrough to couple the first strap to either the firstengaging component or the second engaging component.
 12. The device ofclaim 1, further comprising: a first pad coupled to one or both of thefirst fixed arm and the first expandable arm; and a second pad coupledto one or both of the second fixed arm and the second expandable arm;wherein the first pad and the second pad are configured to engage atleast a portion of a mammalian bodily organ positioned therebetween. 13.The device of claim 1, wherein the first engaging component and thesecond engaging component are configured to engage a targeted tissuetherebetween when the first swivel arm and the second swivel arm are ina configuration relatively perpendicular to the first engaging componentand the second engaging component.
 14. The device of claim 1, whereinthe first engaging component, the second engaging component, the firstswivel arm, and the second swivel arm each comprise a material suitableto resist corrosion selected from the group consisting of polyurethane,polyethylene, polytetrafluoroethylene, polyaryletherketone, carbothane,tecothane, nitinol, silastic, titanium, and stainless steel.
 15. Thedevice of claim 1, wherein each of the first engaging component and thesecond engaging component define one or more facets along at least partof a length of said engaging components, said facets providing agenerally arcuate profile of said engaging components.
 16. The device ofclaim 1, wherein each of the first engaging component and the secondengaging component comprise a configuration chosen from a straight barconfiguration, a curved configuration, or a circular configuration. 17.The device of claim 1, wherein the first engaging component and thesecond engaging component are flexible or semi-flexible.
 18. Animplantable restraining device, comprising: a first engaging componentand a second engaging component at least substantially parallel to oneanother; a first swivel arm, comprising: a first fixed arm, a firstexpandable arm, and a first hub, wherein the first fixed arm ispivotally connected to the first engaging component at or near a firstfixed arm first end and is coupled to the first hub at or near a firstfixed arm second end, and wherein the first expandable arm is pivotallyconnected to the second engaging component at or near a first expandablearm first end and is connected to the first hub at or near a firstexpandable arm second end by way of a first hub bracket; a second swivelarm, comprising: a second fixed arm, a second expandable arm, and asecond hub, wherein the second fixed arm is pivotally connected to thefirst engaging component at or near a second fixed arm first end and iscoupled to the second hub at or near a second fixed arm second end, andwherein the second expandable arm is pivotally connected to the secondengaging component at or near a second expandable arm first end and isconnected to the second hub at or near a second expandable arm secondend by way of a second hub bracket; and a first strap positioned at oneor both of a first end of the first engaging component and at a firstend of the second engaging component, the first strap configured tolimit movement of the first engaging component and the second engagingcomponent when the first strap is coupled to the first engagingcomponent and the second engaging component; wherein the firstexpandable arm and the second expandable are capable of movementrelative to the first hub and the second hub respectively so that adistance between the first engaging component and the second engagingcomponent may change relative to movement of the first expandable armand the second expandable arm; and wherein the first swivel arm iscapable of rotation in a first direction so that the first swivel arm,the second swivel arm, the first engaging component, and the secondengaging component share a common linear axis, and wherein the secondswivel arm is capable of rotation in an opposing second direction sothat the first swivel arm and the second swivel arm are substantially orfully perpendicular to the first engaging component and the secondengaging component.
 19. A method for restoring a targeted tissue, themethod comprising the steps of: inserting an implantable restrainingdevice into a body cavity of a mammalian body, the implantablerestraining device comprising: a first engaging component and a secondengaging component at least substantially parallel to one another; afirst swivel arm, comprising: a first fixed arm, a first expandable arm,and a first hub, wherein the first fixed arm is pivotally connected tothe first engaging component at or near a first fixed arm first end andis coupled to the first hub at or near a first fixed arm second end, andwherein the first expandable arm is pivotally connected to the secondengaging component at or near a first expandable arm first end and isconnected to the first hub at or near a first expandable arm second endby way of a first hub bracket; a second swivel arm, comprising: a secondfixed arm, a second expandable arm, and a second hub, wherein the secondfixed arm is pivotally connected to the first engaging component at ornear a second fixed arm first end and is coupled to the second hub at ornear a second fixed arm second end, and wherein the second expandablearm is pivotally connected to the second engaging component at or near asecond expandable arm first end and is connected to the second hub at ornear a second expandable arm second end by way of a second hub bracket;advancing the implantable restraining device to a location within themammalian body adjacent to a targeted tissue; swiveling the first swivelarm and the second swivel arm so that the first swivel arm and thesecond swivel arm are substantially perpendicular to the first engagingcomponent and the second engaging component; and positioning the firstengaging component and the second engaging component over the targetedtissue such that at least a portion of the targeted tissue is positionedtherebetween, wherein when the targeted tissue expands in a directionbetween the first engaging component and the second engaging component,the targeted tissue exerts a force upon the first engaging component andthe second engaging component so that the first expandable arm movesrelative to the first hub and so that the second expandable arm movesrelative to the second hub.
 20. The method of claim 19, wherein thetargeted tissue is a stomach, and wherein expansion of the stomach, withsaid device positioned thereon, functionally divides the stomach into afirst stomach portion and a second stomach portion.